| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03646 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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
Not provided
Not provided
This randomized pilot clinical trial studies pregabalin in preventing acute pain syndrome in patients receiving paclitaxel. Pregabalin may control the pain caused by cancer treatment.
PRIMARY OBJECTIVES: I. To obtain pilot data regarding the possible effect of pregabalin on pain related to paclitaxel-associated acute pain syndrome (P-APS). SECONDARY OBJECTIVES: I. To obtain pilot data regarding the possible effect of pregabalin on paclitaxel-induced peripheral neuropathy. II. To obtain pilot data regarding the possible relative toxicities related to pregabalin therapy in this study situation. TERTIARY OBJECTIVES: I. To characterize neurological testing abnormalities that might occur with the P-APS, and to evaluate neurological testing abnormalities during the period of the longer-term chemotherapy-induced peripheral neuropathy (CIPN). II. To determine the PRO incidence and characteristics of, and change in, P-APS and paclitaxel induced more chronic CIPN over several cycles. These data will serve to confirm the results obtained in our previous natural history study N08C1. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive pregabalin orally (PO) twice daily (BID), beginning on the first night of chemotherapy, for 12 weeks and then once daily (QD) for 1 week. ARM II: Patients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. After completion of study treatment, patients are followed up every 30 days for 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (pain therapy) | Experimental | Patients receive pregabalin PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. |
|
| Arm II (placebo) | Placebo Comparator | Patients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Worst of the Pain Scores for the Week Following the First Cycle of Paclitaxel Administration, Paclitaxel-associated Acute Pain Syndrome (P-APS) Pain Score | Worst of the pain scores for the week following the first cycle of paclitaxel administration, as measured by a question on the daily post-paclitaxel questionnaire. Worst pain over the first 6 days following treatment initiation. Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be). | From treatment initiation to 6 days following treatment initiation; up to 7 days |
| Maximum of the Average Pain Scores (Item 3, Appendix IV) Over the Period From Treatment Initiation to Day 7 (for Cycle 1). | Maximum of average pain scores over 6 days following initiation of treatment. Average pain over the first 6 days following treatment initiation. Maximum of the average pain scores (item 3, appendix IV; "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.") over the period from treatment initiation to day 7 (for cycle 1). Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be). | From treatment initiation to 6 days following treatment initiation; up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve Per Assessment (aAUCpa) of Worst, Average and Least Pain (Items 1-3 Appendix IV) for the First Cycle of Treatment. | Average Area Under the Curve per assessment (aAUCpa) of worst, average, and least pain (items 1-3 app. IV; "Please rate any aches/pains that are NEW since your last dose of paclitaxel, and that you think might be related to your chemotherapy treatment by circling ONE number that best describes your aches/pains at its WORST in the last 24 hours.", "Please rate the same aches/pains by circling the ONE number that best describes your aches/pains at its LEAST in the last 24 hours.", "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.") for the first cycle of treatment. Scores are reported on a 0-100 scale, where 100=better outcome QOL. The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the day-6 assessment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charles Loprinzi | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center of Kansas | Wichita | Kansas | 67214 | United States | ||
| Essentia Health-Duluth CCOP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Pregabalin) | Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. |
| FG001 | Arm II (Placebo) | Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Pregabalin) | Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. |
| BG001 | Arm II (Placebo) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Worst of the Pain Scores for the Week Following the First Cycle of Paclitaxel Administration, Paclitaxel-associated Acute Pain Syndrome (P-APS) Pain Score | Worst of the pain scores for the week following the first cycle of paclitaxel administration, as measured by a question on the daily post-paclitaxel questionnaire. Worst pain over the first 6 days following treatment initiation. Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be). | Posted | Mean | Standard Deviation | units on a scale | From treatment initiation to 6 days following treatment initiation; up to 7 days |
|
Time Frame: Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment
The revised NCI Common Terminology Criteria for AE (CTCAE) version 4.0 will be utilized for AE reporting. Cancels and Withdrawal by Subject in the Participant Flow table did not receive treatment. Serious AE (SAE) reports for this study may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited Adverse Events (EAEs), and appear in the SAE table.
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 | Arm I (Pregabalin) | Patients receive pregabalin (75 mg (one capsule)) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hearing impaired | Ear and labyrinth disorders | MedDRA 12 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles L. Loprinzi, M.D. | Mayo Clinic | 507/284-1623 | loprinzi.charles@mayo.edu |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | Given PO |
|
|
| questionnaire administration | Other | Ancillary studies |
|
| From treatment initiation to 6 days following treatment initiation; up to 7 days |
| Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment | The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below. | Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment |
| The Percentage of Patients Who Use Non-prescription Pain Medications | The percentage of patients who use non-prescription pain medications are reported by arm below. | From treatment initiation to 6 months. |
| The Percentage of Patients Taking Opioid Medications | The percentage of patients taking opioid medications are reported below by arm. | From treatment initiation to 6 months. |
| The Percentage of Patients Who Report the Development of New Aches/Pains That They Attribute to Paclitaxel | The percentage of patients who report the development of new aches/pains that they attribute to paclitaxel in the first week of chemotherapy are reported by arm below. | From treatment initiation to 6 days following treatment initiation; up to 7 days |
| The Worst Pain Reported at the End of the Week for the Overall Week (Item 2 Appendix V) | The worst pain reported at the end of the week for the overall week ("New aches and pains at their worst over the past week") are reported below. This question was only supposed to be answered by patients who responded "yes" to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not. The worst pain reported at the end of the week for the overall week (item 2 appendix V: "Please rate any aches/pains that you have by circling ONE number that best describes your aches/pains at its worst over the last week.") Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be). | From treatment initiation to 6 days following treatment initiation; up to 7 days |
| The Percentage of Patients Who Report, at Week's End, Using Non-prescription Pain Medications | The percentage of patients who report, at week's end, using non-prescription pain medications ("Have you used non-prescription meds like aspirin, Tylenol, Motrin, Ibuprofen, or Advil over the past week?") are reported by arm below. This question was only supposed to be answered by patients who responded "yes" to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not. | From treatment initiation to 6 days following treatment initiation; up to 7 days |
| The Percentage of Patients Who Report, at Week's End, Using Opioids | The percentage of patients who report, at week's end, using opioids ("Have you used opioids like codeine, oxycodone, or morphine for this pain over the past week?") are reported by arm below. This question was only supposed to be answered by patients who responded "yes" to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not. | From treatment initiation to 6 days following treatment initiation; up to 7 days |
| Area Under the Curve (AUC) of EORTC Sensory, Autonomic, and Motor Neuropathy Subscales | Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neurophathy Module (EORTC QLQ-CIPN20) Sensory, Autonomic, and Motor Neuropathy Subscales. The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48), motor (items 37, 38, 41-45, 49), and autonomic (items 46, 47, 50) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the 6-month assessment. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to 6-months are averaged to yield the aAUCpa per patient per subcale. | From treatment initiation to 6 months. |
| Duluth |
| Minnesota |
| 55805 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Coborn Cancer Center at Saint Cloud Hospital | Saint Cloud | Minnesota | 56303 | United States |
| Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | 54449 | United States |
| No cycle 1 questionnaire data |
|
Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. |
|
|
|
| Primary | Maximum of the Average Pain Scores (Item 3, Appendix IV) Over the Period From Treatment Initiation to Day 7 (for Cycle 1). | Maximum of average pain scores over 6 days following initiation of treatment. Average pain over the first 6 days following treatment initiation. Maximum of the average pain scores (item 3, appendix IV; "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.") over the period from treatment initiation to day 7 (for cycle 1). Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be). | Posted | Mean | Standard Deviation | units on a scale | From treatment initiation to 6 days following treatment initiation; up to 7 days |
|
|
|
|
| Secondary | Area Under the Curve Per Assessment (aAUCpa) of Worst, Average and Least Pain (Items 1-3 Appendix IV) for the First Cycle of Treatment. | Average Area Under the Curve per assessment (aAUCpa) of worst, average, and least pain (items 1-3 app. IV; "Please rate any aches/pains that are NEW since your last dose of paclitaxel, and that you think might be related to your chemotherapy treatment by circling ONE number that best describes your aches/pains at its WORST in the last 24 hours.", "Please rate the same aches/pains by circling the ONE number that best describes your aches/pains at its LEAST in the last 24 hours.", "Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.") for the first cycle of treatment. Scores are reported on a 0-100 scale, where 100=better outcome QOL. The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the day-6 assessment. | The number analyzed for average pain over the past 24 hours differs from the overall number analyzed due to missing data. | Posted | Mean | Standard Deviation | average(subscale value*assessment) | From treatment initiation to 6 days following treatment initiation; up to 7 days |
|
|
|
|
| Secondary | Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment | The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below. | Posted | Number | percentage of patients | Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment |
|
|
|
| Secondary | The Percentage of Patients Who Use Non-prescription Pain Medications | The percentage of patients who use non-prescription pain medications are reported by arm below. | Posted | Number | percentage of patients | From treatment initiation to 6 months. |
|
|
|
|
| Secondary | The Percentage of Patients Taking Opioid Medications | The percentage of patients taking opioid medications are reported below by arm. | Posted | Number | percentage of patients | From treatment initiation to 6 months. |
|
|
|
|
| Secondary | The Percentage of Patients Who Report the Development of New Aches/Pains That They Attribute to Paclitaxel | The percentage of patients who report the development of new aches/pains that they attribute to paclitaxel in the first week of chemotherapy are reported by arm below. | Posted | Number | percentage of patients | From treatment initiation to 6 days following treatment initiation; up to 7 days |
|
|
|
|
| Secondary | The Worst Pain Reported at the End of the Week for the Overall Week (Item 2 Appendix V) | The worst pain reported at the end of the week for the overall week ("New aches and pains at their worst over the past week") are reported below. This question was only supposed to be answered by patients who responded "yes" to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not. The worst pain reported at the end of the week for the overall week (item 2 appendix V: "Please rate any aches/pains that you have by circling ONE number that best describes your aches/pains at its worst over the last week.") Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be). | Posted | Mean | Standard Deviation | units on a scale | From treatment initiation to 6 days following treatment initiation; up to 7 days |
|
|
|
|
| Secondary | The Percentage of Patients Who Report, at Week's End, Using Non-prescription Pain Medications | The percentage of patients who report, at week's end, using non-prescription pain medications ("Have you used non-prescription meds like aspirin, Tylenol, Motrin, Ibuprofen, or Advil over the past week?") are reported by arm below. This question was only supposed to be answered by patients who responded "yes" to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not. | Posted | Number | percentage of patients | From treatment initiation to 6 days following treatment initiation; up to 7 days |
|
|
|
|
| Secondary | The Percentage of Patients Who Report, at Week's End, Using Opioids | The percentage of patients who report, at week's end, using opioids ("Have you used opioids like codeine, oxycodone, or morphine for this pain over the past week?") are reported by arm below. This question was only supposed to be answered by patients who responded "yes" to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not. | Posted | Number | percentage of patients | From treatment initiation to 6 days following treatment initiation; up to 7 days |
|
|
|
|
| Secondary | Area Under the Curve (AUC) of EORTC Sensory, Autonomic, and Motor Neuropathy Subscales | Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neurophathy Module (EORTC QLQ-CIPN20) Sensory, Autonomic, and Motor Neuropathy Subscales. The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48), motor (items 37, 38, 41-45, 49), and autonomic (items 46, 47, 50) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the 6-month assessment. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to 6-months are averaged to yield the aAUCpa per patient per subcale. | Posted | Mean | Standard Deviation | average(subscale value*assessment) | From treatment initiation to 6 months. |
|
|
|
|
| 0 |
| 21 |
| 1 |
| 21 |
| 15 |
| 21 |
| EG001 | Arm II (Placebo) | Patients receive placebo (one capsule) PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. | 0 | 22 | 1 | 22 | 21 | 22 |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Edema limbs | General disorders | MedDRA 12 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12 | Systematic Assessment |
|
| CD4 lymphocytes decreased | Investigations | MedDRA 12 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 12 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 12 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Average pain over the past 24 hours |
|
|
| Least pain over the past 24 hours |
|
|
| 0.22 |
| Superiority |
| Least pain over the past 24 hours | Kruskal-Wallis | 0.07 | Superiority |
| Motor |
|
| 0.86 |
| Superiority |
| Motor neuropathy | Kruskal-Wallis | 0.40 | Superiority |