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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00075181 | Other Identifier | University of Michigan | |
| HCI94979 | Other Identifier | University of Utah |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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Early stage breast cancer is typically treated with surgery, chemotherapy, radiation therapy, and/or endocrine therapy. Following treatment, 25-60% of breast cancer survivors have reported chronic pain, which can be difficult to manage. Duloxetine is a serotonin norepinephrine reuptake inhibitor that is FDA approved for treatment of depression, anxiety, fibromyalgia, diabetic neuropathic pain, knee arthritis, and low back pain.
Pilot data suggest that duloxetine is effective in management of endocrine therapy-associated musculoskeletal pain, and a randomized placebo controlled trial of duloxetine has demonstrated efficacy for treatment of chemotherapy-induced neuropathic pain. In this mechanistic study of duloxetine, we will investigate the change in pain sensitivity with treatment in order to evaluate both why duloxetine is effective for management of pain for some patients, as well as predictors of who is likely to benefit from duloxetine. A total of 84 women with early stage breast cancer who have chronic pain following treatment, as well as 48 women who are pain free, will be enrolled. All subjects will undergo assessment of pain sensitivity and complete questionnaires. Subjects with pain will be treated with duloxetine for a total of 7 weeks, with pain sensitivity assessments before treatment and after 4 weeks of full-dose treatment.
Early stage breast cancer is typically treated with surgery, chemotherapy, radiation therapy, and/or endocrine therapy. Following treatment, 25-60% of breast cancer survivors have reported chronic pain, which can be difficult to manage. Duloxetine is a serotonin norepinephrine reuptake inhibitor that is FDA approved for treatment of depression, anxiety, fibromyalgia, diabetic neuropathic pain, knee arthritis, and low back pain.
Data from a randomized, placebo-controlled clinical trial of duloxetine demonstrated that it is effective in management of both aromatase inhibitor-associated musculoskeletal pain and chemotherapy-induced neuropathic pain. In this mechanistic study, we investigated the change in pain sensitivity with treatment in order to evaluate both why duloxetine is effective for management of pain for some patients, as well as predictors of who is likely to benefit from duloxetine. The original protocol was designed as a randomized, placebo-controlled cross-over trial, with planned enrollment of a total of 84 women with early stage breast cancer who have chronic pain following treatment, as well as 48 women who are pain free. However because of challenges with logistics of the protocol and pain testing, the trial was redesigned after only 7 patients with pain were enrolled. The new design was a single arm trial, and all patients with pain were treated with duloxetine (no placebo); there was still a non-treatment comparator arm of patients without pain. Patients were enrolled first at the University of Michigan and then the University of Utah. A total of 39 patients with pain and 43 controls without pain were enrolled before the trial closed to enrollment. All subjects underwent assessment of pain sensitivity and completed questionnaires. Subjects with pain were treated with duloxetine for a total of 7 weeks, with pain sensitivity assessments before treatment and after 4 weeks of full-dose treatment. The data from the control patients (who did not receive any study medication) are being compared to those from the patients with pain to understand more about the differences between patients who do and do not experience treatment-related pain, and to interpret the post-intervention patient-reported and pain assessment results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (Patients with pain, duloxetine) | Experimental | Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks. |
|
| Arm 2 (Patients without pain -- control) | No Intervention | Patient reported pain and symptoms assessment for comparison at baseline. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-reported Worst Pain Between Baseline and 5 Weeks of Treatment With Duloxetine | Worst pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.
| 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-reported Average Pain Between Baseline and 5 Weeks of Treatment With Duloxetine | Average pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.
|
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Inclusion Criteria:
Exclusion Criteria:
Controls are patients without chronic pain who otherwise meet the following eligibility criteria (inclusion #1, 2, 8, exclusion #1, 2, 4, 5, worst pain score 0-1, and not currently on medication for pain)
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| Name | Affiliation | Role |
|---|---|---|
| Lynn Henry, MD, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48103 | United States | ||
| Huntsman Cancer Institute |
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3 cases randomized to placebo are not included in the analysis. See study description in protocol section for explanation. 3 patients on Arm 2 consented but withdrew prior to participation. 1 patient on Arm 1 withdrew permission to use her data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 (Patients With Pain) | Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks. Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days. Surveys administered at baseline and at 5 weeks. |
| FG001 | Arm 2 (Patients Without Pain -- Control) | Surveys administered at baseline only. |
| FG002 | Arm 3 - Placebo (Withdrawn) | Because of challenges with logistics of the protocol and pain testing, the trial was redesigned after only 7 patients with pain were enrolled. Three of the patients had been assigned to placebo arm. This arm is not included in any analysis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Excluding the 1 patient in Arm 1 who withdrew consent
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 (Patients With Pain) | Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks. Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days. |
| BG001 | Arm 2 (Patients Without Pain -- Control) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Change in Patient-reported Worst Pain Between Baseline and 5 Weeks of Treatment With Duloxetine | Worst pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
|
Adverse Event (AE) data were collected from date of study drug administration until 14 days after completion of study drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 (Patients With Pain) | Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks. Duloxetine: Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| congestive heart failure | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynn Henry, MD, PhD | University of Michigan Rogel Cancer Center | 734-936-9868 | norahh@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2020 | Jun 26, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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Trial was initially a randomized cross-over design. Soon after study initiation the trial design was amended because of poor accrual, and instead was a single arm open label trial in which all patients with pain were treated with study drug. Since so few patients had been enrolled at the time of study redesign, the only data analyzed were from the single treatment arm portion of the trial, and the non-intervention (baseline only) comparator.
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|
| 5 weeks |
| Change in Pain Interference Between Baseline and 5 Weeks of Treatment With Duloxetine | Pain interference will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.
| 5 weeks |
| Change in Number of Sites of Pain Between Baseline and 5 Weeks of Treatment With Duloxetine | Number of sites of pain will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map.
| 5 weeks |
| Change in Fibromyalgia Symptom Severity Score Between Baseline and 5 Weeks of Treatment With Duloxetine | Fibromyalgia Symptom Severity Score will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map and Symptom Severity Scale.
| 5 weeks |
| Change in PainDETECT Score Between Baseline and 5 Weeks of Treatment With Duloxetine | PainDETECT score will be assessed at baseline and 5 weeks for each individual patient using the PainDETECT questionnaire.
| 5 weeks |
| Change in Neuropathy Between Baseline and 5 Weeks of Treatment With Duloxetine | Neuropathy will be assessed at baseline and 5 weeks for each individual patient using the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) questionnaire.
| 5 weeks |
| Change in Fatigue Between Baseline and 5 Weeks of Treatment With Duloxetine | Fatigue will be assessed at baseline and 5 weeks for each individual patient using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.
| 5 weeks |
| Change in Sleep Disturbance Between Baseline and 5 Weeks of Treatment With Duloxetine | Sleep Disturbance will be assessed at baseline and 5 weeks for each individual patient using the PROMIS Sleep Disturbance Short Form 8b v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.
| 5 weeks |
| Change in Physical Function Between Baseline and 5 Weeks of Treatment With Duloxetine | Physical Function will be assessed at baseline and 5 weeks for each individual patient using the PROMIS Physical Function Short Form 10a v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.
| 5 weeks |
| Change in Anxiety Between Baseline and 5 Weeks of Treatment With Duloxetine | Anxiety will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale.
| 5 weeks |
| Change in Depression Between Baseline and 5 Weeks of Treatment With Duloxetine | Depression will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale.
| 5 weeks |
| Change in Cognitive Difficulties - Language Between Baseline and 5 Weeks of Treatment With Duloxetine | Cognitive Difficulties - Language will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
| 5 weeks |
| Change in Cognitive Difficulties - Visual-Perceptual Ability Between Baseline and 5 Weeks of Treatment With Duloxetine | Cognitive Difficulties - Visual-Perceptual Ability will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
| 5 weeks |
| Change in Cognitive Difficulties - Verbal Memory Between Baseline and 5 Weeks of Treatment With Duloxetine | Cognitive Difficulties - Verbal Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
| 5 weeks |
| Change in Cognitive Difficulties - Visual-Spatial Memory Between Baseline and 5 Weeks of Treatment With Duloxetine | Cognitive Difficulties - Visual-Spatial Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
| 5 weeks |
| Change in Cognitive Difficulties - Attention/Concentration Between Baseline and 5 Weeks of Treatment With Duloxetine | Cognitive Difficulties - Attention/Concentration will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
| 5 weeks |
| Change in Objectively Assessed Pain Sensitivity Between Baseline and 5 Weeks of Treatment With Duloxetine | Pain sensitivity will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing to assess pressure pain threshold (Pain50).
| 5 weeks |
| Change in Objectively Assessed Conditioned Pain Modulation Between Baseline and 5 Weeks of Treatment With Duloxetine | Conditioned pain modulation (CPM) will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing
| 5 weeks |
| Salt Lake City |
| Utah |
| 84112 |
| United States |
| Study design change |
|
Patient reported pain and symptoms assessment for comparison at baseline. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Arm 2 (Patients Without Pain -- Control) | Patient reported pain and symptoms assessment for comparison at baseline. |
|
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| Secondary | Change in Patient-reported Average Pain Between Baseline and 5 Weeks of Treatment With Duloxetine | Average pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
|
|
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| Secondary | Change in Pain Interference Between Baseline and 5 Weeks of Treatment With Duloxetine | Pain interference will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. 1 patient in Arm 1 had missing data at baseline and the score could not be generated. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
|
|
|
| Secondary | Change in Number of Sites of Pain Between Baseline and 5 Weeks of Treatment With Duloxetine | Number of sites of pain will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. | Posted | Mean | Full Range | number of sites | 5 weeks |
|
|
|
| Secondary | Change in Fibromyalgia Symptom Severity Score Between Baseline and 5 Weeks of Treatment With Duloxetine | Fibromyalgia Symptom Severity Score will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map and Symptom Severity Scale.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. 1 patient in Arm 1 had missing data at baseline and the score could not be generated. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
|
|
|
| Secondary | Change in PainDETECT Score Between Baseline and 5 Weeks of Treatment With Duloxetine | PainDETECT score will be assessed at baseline and 5 weeks for each individual patient using the PainDETECT questionnaire.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. 1 patient in Arm 1 had missing data at baseline and 3 patients had missing data at week 5 and the scores could not be generated. | Posted | Mean | Standard Deviation | score on questionnaire | 5 weeks |
|
|
|
| Secondary | Change in Neuropathy Between Baseline and 5 Weeks of Treatment With Duloxetine | Neuropathy will be assessed at baseline and 5 weeks for each individual patient using the Functional Assessment of Cancer Therapy-Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) questionnaire.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. 1 patient in Arm 1 at baseline, 1 patient in Arm 1 at week 5, and 1 patient in Arm 2 had missing data and the scores could not be generated. | Posted | Mean | Standard Deviation | score on questionnaire | 5 weeks |
|
|
|
| Secondary | Change in Fatigue Between Baseline and 5 Weeks of Treatment With Duloxetine | Fatigue will be assessed at baseline and 5 weeks for each individual patient using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. | Posted | Mean | Standard Deviation | T score | 5 weeks |
|
|
|
| Secondary | Change in Sleep Disturbance Between Baseline and 5 Weeks of Treatment With Duloxetine | Sleep Disturbance will be assessed at baseline and 5 weeks for each individual patient using the PROMIS Sleep Disturbance Short Form 8b v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. | Posted | Mean | Standard Deviation | T score | 5 weeks |
|
|
|
| Secondary | Change in Physical Function Between Baseline and 5 Weeks of Treatment With Duloxetine | Physical Function will be assessed at baseline and 5 weeks for each individual patient using the PROMIS Physical Function Short Form 10a v1.0 questionnaire. Raw scores are converted to standardized T scores based on national norms for patients with cancer.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. | Posted | Mean | Standard Deviation | T score | 5 weeks |
|
|
|
| Secondary | Change in Anxiety Between Baseline and 5 Weeks of Treatment With Duloxetine | Anxiety will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. 1 patient in Arm 1 had missing data at baseline and the score could not be generated. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
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|
|
| Secondary | Change in Depression Between Baseline and 5 Weeks of Treatment With Duloxetine | Depression will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. 1 patient in Arm 1 at baseline and 1 patient in Arm 2 had missing data and the scores could not be generated. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
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|
|
| Secondary | Change in Cognitive Difficulties - Language Between Baseline and 5 Weeks of Treatment With Duloxetine | Cognitive Difficulties - Language will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. 1 patient in Arm 1 at week 5 had missing data and the score could not be generated. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
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| Secondary | Change in Cognitive Difficulties - Visual-Perceptual Ability Between Baseline and 5 Weeks of Treatment With Duloxetine | Cognitive Difficulties - Visual-Perceptual Ability will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. 1 patient in Arm 1 at baseline, 1 patient in Arm 1 at week 5, and 1 patient in Arm 2 had missing data and the scores could not be generated. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
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| Secondary | Change in Cognitive Difficulties - Verbal Memory Between Baseline and 5 Weeks of Treatment With Duloxetine | Cognitive Difficulties - Verbal Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. 1 patient in Arm 1 at baseline, 1 patient in arm 1 at week 5, and 1 patient in Arm 2 had missing data and the scores could not be generated. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
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| Secondary | Change in Cognitive Difficulties - Visual-Spatial Memory Between Baseline and 5 Weeks of Treatment With Duloxetine | Cognitive Difficulties - Visual-Spatial Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. 1 patient in Arm 1 at week 5 and 1 patient in Arm 2 had missing data and the scores could not be generated. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
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| Secondary | Change in Cognitive Difficulties - Attention/Concentration Between Baseline and 5 Weeks of Treatment With Duloxetine | Cognitive Difficulties - Attention/Concentration will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire.
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. 1 patient in Arm 1 at baseline, 1 patient in Arm 1 at week 5, and 1 patient in Arm 2 had missing data and the scores could not be generated. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
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| Secondary | Change in Objectively Assessed Pain Sensitivity Between Baseline and 5 Weeks of Treatment With Duloxetine | Pain sensitivity will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing to assess pressure pain threshold (Pain50).
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. 1 patient in Arm 1 had missing data at week 5 and the score could not be generated. | Posted | Mean | Standard Deviation | kg/cm2 | 5 weeks |
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| Secondary | Change in Objectively Assessed Conditioned Pain Modulation Between Baseline and 5 Weeks of Treatment With Duloxetine | Conditioned pain modulation (CPM) will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing
| Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5. 1 patient in Arm 1 at baseline, 1 patient in Arm 1 at week 5, and 2 patients in Arm 2 had missing data and the scores could not be generated. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks |
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| 0 |
| 35 |
| 1 |
| 35 |
| 10 |
| 35 |
| EG001 | Arm 2 (Patients Without Pain -- Control) | Patient reported pain and symptoms assessment for comparison at baseline. | 0 | 40 | 0 | 40 | 0 | 40 |
| headache | Nervous system disorders | Non-systematic Assessment |
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| insomnia | Psychiatric disorders | Non-systematic Assessment |
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| fatigue | General disorders | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006571 |
| Heterocyclic Compounds |
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