Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IB-MEDOR | Other Identifier | Institute Bergonie | |
| INCA-RECF0498 | Other Grant/Funding Number | INCA | |
| 2007-002686-13 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Morphine may reduce pain in patients who have undergone radiofrequency ablation to remove bone metastases.
PURPOSE: This phase II trial is studying how well morphine works after radiofrequency ablation of painful bone metastases in patients with cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients complete a pain questionnaire over 1 week before undergoing radiofrequency ablation (RFA). Patients also complete questionnaires about pain, physical performance, quality of life (QOL), and anxiety at baseline.
Bone metastases are removed by radiofrequency ablation (RFA). After surgery, patients receive acetaminophen and patient-controlled analgesic (PCA) morphine sulfate. PCA morphine sulfate continues with a dose increase of 50% bolus every 24 hours. Patients with maximum pain less than or equal to that at inclusion receive standard morphine sulfate therapy instead.
Data concerning the total dose of PCA morphine sulfate; minimum, average, and maximum pain intensity; side effects and complications of RFA; and total dose of morphine sulfate (or equivalent) is collected daily.
Pain is assessed at 4 and 8 weeks after RFA. Patients complete follow-up questionnaires about physical performance, QOL, and anxiety at 12 weeks. Patients also undergo a CT scan at 12 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient who has undergone radiofrequency ablation of bone metastases | Experimental | Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Intravenous administration of paracetamol (4 g / 24h) and patient-controlled analgesia (PCA). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA) | Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to an 11-point numerical scale Rate of patients with a decrease of two or more points in their most intense pain, 2 months after the radiofrequency ablation. This rate is calculated for the evaluable population for the principal outcome measure. This rate is equal to the ratio of the number of patients with a decrease of two or more points in their maximum pain divided by the size of the evaluable population. The response rate considered acceptable is 50%, above this threshold the treatment will be considered potentially effective and may be proposed in phase III. | 2 months after radiofrequency ablation (RFA) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation | Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to a discrete 11-points numerical scale. Increased/decreased pain is considered as a variation of at least one point on the numerical scale. If 25 patients or more are observed with pain reduction of 2 or more points, then the treatment will be considered potentially effective. |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed cancer
Painful bone metastases despite radiotherapy or symptomatic relapse into previously irradiated area with no possibility of repeating radiotherapy
Bone metastases may have been treated with bisphosphonates
Osteolytic bone or joint (lytic and condensed) confirmed by CT scan and meeting the following criteria:
Lesion size ≤ 5 cm
No more than 2 painful bone metastases
Metastatic bone lesions of the pelvis, sacrum (in absence of canal involvement), ribs, or long bones allowed
Pain located at the tumor or in the area
Maximum pain in the last 24 hours > 4 points (numerical scale to 11 points)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Florence Dixmerias, MD | Institut Bergonié | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute Bergonié | Bordeaux | 33076 | France |
Not provided
| Label | URL |
|---|---|
| National Cancer Institute | View source |
| KUSAJILI | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases Localized Causing Pain | Bone metastases refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Morphine Sulfate | Drug | Patient-controlled analgesia (PCA), allowing morphine consumption to be titrated to the patient's needs and thus allowing morphine doses to be adapted to an increase in pain in the patient's post-operative period or a rapid analgesic effect of radiofrequency. |
|
|
| Questionnaire administration | Other | Pain notebook will allow the patient to describe the pain specific to the metastasis concerned, containing information on :
|
|
| Quality-of-life assessment | Procedure | Patients' quality of life will be assessed using the quality of life questionnaire EORTC QLQ-C30 at inclusion in the study and at 8 weeks after radiofrequency. ablation. |
|
| Radiofrequency ablation | Procedure | Recent technique of thermal destruction of tumors. This technique consists of inserting an electrode needle into the tumour under X-ray or ultrasound guidance or intraoperatively under laparoscopy for example. This needle carries a current or a light wave depending on the characteristics of the generator to which it is connected (radiofrequency, laser). Radio frequencies are radiation non-ionising electromagnets. In this context of tissue ablathermia wavelengths ranging from 400kHz to 500kHz. |
|
| Inclusion and 2 months after radiofrequency ablation (RFA) |
| Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected at the pre-selection visit. | First algology assessment at pre-selection visit |
| Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected at the inclusion visit. | Second algology assessment at inclusion visit |
| Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected one day before radiofrequency (J-1). | Algology assessment one day before radiofrequency (J-1) |
| Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected one day after radiofrequency (J+1). | Algology assessment one day after radiofrequency: J+1 |
| Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected at the discharge from hospital visit. | Algology assessment at the discharge from hospital visit |
| Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected 7 days after discharge from hospital. | Algology assessment 7 days after discharge from hospital |
| Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected 1 month after radiofrequency. | Algology assessment 1 month after radiofrequency |
| Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected 2 months after radiofrequency. | Algology assessment 2 months after radiofrequency |
| Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected 3 months after radiofrequency. | Algology assessment 3 months after radiofrequency |
| Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | Preselection: First algology visit (within a week (± 3 days) after the radiology consultation) |
| Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | Inclusion: Second algology visit (One week after the first algology visit) |
| Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | J-1 (One day before radiofrequency) |
| Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | Discharge from hospital |
| Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | 7 days after discharge |
| Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | 1 month after radiofrequency |
| Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | 2 months after radiofrequency |
| Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | 3 months after radiofrequency |
| Total Intravenous Morphine Dose (mg) | Total intravenous dose of morphine 24 hours after the radiofrequency was assessed during the patient's hospital stay. As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA). | 24 hours after radiofrequency |
| Bolus Dose in mg Administered by Patient-controlled Analgesia (PCA) | As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA). | 24 hours after radiofrequency |
| Standardised Quality of Life Scores (EORTC - QLQ-C30) | Quality of life Questionnaire -Core 30 (QLQ-C30) developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) assesses quality of life across 15 dimensions : 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties; 1 global health dimension: Global health status/QoL Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health. | Inclusion |
| Standardised Quality of Life Scores (EORTC - QLQ-C30) | Quality of life Questionnaire -Core 30 (QLQ-C30) developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) assesses quality of life across 15 dimensions : 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties; 1 global health dimension: Global health status/QoL Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health. | 2 months after radiofrequency |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA) | Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to an 11-point numerical scale Rate of patients with a decrease of two or more points in their most intense pain, 2 months after the radiofrequency ablation. This rate is calculated for the evaluable population for the principal outcome measure. This rate is equal to the ratio of the number of patients with a decrease of two or more points in their maximum pain divided by the size of the evaluable population. The response rate considered acceptable is 50%, above this threshold the treatment will be considered potentially effective and may be proposed in phase III. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. If 25 patients or more are observed with pain reduction of 2 or more points, then the treatment will be considered potentially effective. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 months after radiofrequency ablation (RFA) |
|
|
| |||||||||||||||||||||||||
| Secondary | Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation | Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to a discrete 11-points numerical scale. Increased/decreased pain is considered as a variation of at least one point on the numerical scale. If 25 patients or more are observed with pain reduction of 2 or more points, then the treatment will be considered potentially effective. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Count of Participants | Participants | Inclusion and 2 months after radiofrequency ablation (RFA) |
|
| |||||||||||||||||||||||||||
| Secondary | Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected at the pre-selection visit. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | score on a scale | First algology assessment at pre-selection visit |
| |||||||||||||||||||||||||||
| Secondary | Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected at the inclusion visit. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | score on a scale | Second algology assessment at inclusion visit |
| |||||||||||||||||||||||||||
| Secondary | Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected one day before radiofrequency (J-1). | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | score on a scale | Algology assessment one day before radiofrequency (J-1) |
| |||||||||||||||||||||||||||
| Secondary | Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected one day after radiofrequency (J+1). | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | score on a scale | Algology assessment one day after radiofrequency: J+1 |
| |||||||||||||||||||||||||||
| Secondary | Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected at the discharge from hospital visit. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | score on a scale | Algology assessment at the discharge from hospital visit |
| |||||||||||||||||||||||||||
| Secondary | Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected 7 days after discharge from hospital. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | score on a scale | Algology assessment 7 days after discharge from hospital |
| |||||||||||||||||||||||||||
| Secondary | Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected 1 month after radiofrequency. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | score on a scale | Algology assessment 1 month after radiofrequency |
| |||||||||||||||||||||||||||
| Secondary | Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected 2 months after radiofrequency. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | score on a scale | Algology assessment 2 months after radiofrequency |
| |||||||||||||||||||||||||||
| Secondary | Intensity of Pain (Minimum, Average, Maximum) | According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at:
Here, are presented only data collected 3 months after radiofrequency. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | score on a scale | Algology assessment 3 months after radiofrequency |
| |||||||||||||||||||||||||||
| Secondary | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | mg morphine equivalents/day | Preselection: First algology visit (within a week (± 3 days) after the radiology consultation) |
|
| ||||||||||||||||||||||||||
| Secondary | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | mg morphine equivalents/day | Inclusion: Second algology visit (One week after the first algology visit) |
|
| ||||||||||||||||||||||||||
| Secondary | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | mg morphine equivalents/day | J-1 (One day before radiofrequency) |
|
| ||||||||||||||||||||||||||
| Secondary | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | mg morphine equivalents/day | Discharge from hospital |
|
| ||||||||||||||||||||||||||
| Secondary | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | mg morphine equivalents/day | 7 days after discharge |
|
| ||||||||||||||||||||||||||
| Secondary | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | mg morphine equivalents/day | 1 month after radiofrequency |
|
| ||||||||||||||||||||||||||
| Secondary | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | mg morphine equivalents/day | 2 months after radiofrequency |
|
| ||||||||||||||||||||||||||
| Secondary | Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day | Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | mg morphine equivalents/day | 3 months after radiofrequency |
|
| ||||||||||||||||||||||||||
| Secondary | Total Intravenous Morphine Dose (mg) | Total intravenous dose of morphine 24 hours after the radiofrequency was assessed during the patient's hospital stay. As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA). | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | mg | 24 hours after radiofrequency |
|
| ||||||||||||||||||||||||||
| Secondary | Bolus Dose in mg Administered by Patient-controlled Analgesia (PCA) | As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA). | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | mg | 24 hours after radiofrequency |
|
| ||||||||||||||||||||||||||
| Secondary | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Quality of life Questionnaire -Core 30 (QLQ-C30) developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) assesses quality of life across 15 dimensions : 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties; 1 global health dimension: Global health status/QoL Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | score on a scale | Inclusion |
|
| ||||||||||||||||||||||||||
| Secondary | Standardised Quality of Life Scores (EORTC - QLQ-C30) | Quality of life Questionnaire -Core 30 (QLQ-C30) developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) assesses quality of life across 15 dimensions : 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties; 1 global health dimension: Global health status/QoL Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health. | Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. | Posted | Median | Standard Deviation | score on a scale | 2 months after radiofrequency |
|
All expected (SAE-E) and unexpected (SAE-U) serious adverse events, whether or not attributable to the research, that occur during the study or within 30 days afterwards. A serious adverse event report form (initial or follow-up) must be completed. According to the context Adverse Event (AE) not including serious has not been collected for this study.
Adverse Event (AE) not including serious has not been collected for this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases | Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment. | 10 | 71 | 33 | 71 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile aplasia | Blood and lymphatic system disorders | CTCAE V3.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE V3.0 | Systematic Assessment |
| |
| Alteration of the general condition | General disorders | CTCAE V3.0 | Systematic Assessment |
| |
| Disease-related death | General disorders | CTCAE V3.0 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE V3.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE V3.0 | Systematic Assessment | Febrile syndrome (in the absence of neutropenia, where neutropenia is defined as absolute neutrophil count (ANC) <1.0 x 10e9/L) |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE V3.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE V3.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | CTCAE V3.0 | Systematic Assessment | Compression of the bile ducts |
|
| Sciatalgy | Nervous system disorders | CTCAE V3.0 | Systematic Assessment |
| |
| Immediate post-operative pain increase | Injury, poisoning and procedural complications | CTCAE V3.0 | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE V3.0 | Systematic Assessment |
| |
| Dysuric syndrome | Renal and urinary disorders | CTCAE V3.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jean Palussière | Institute Bergonie | 05 56 33 37 50 | j.palussiere@bordeaux.unicancer.fr |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D009020 | Morphine |
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|