Mechanistic Study of Duloxetine in Breast Cancer Patients With Chronic Pain

• Sponsor: University of Michigan Rogel Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01912612
• Collaborator: American Cancer Society, Inc. (Other)
• Enrollment: 82
• Locations: 2
• Arms: 2
• Actual Duration (Months): 67.9
• Patients Per Site: 41
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Duloxetine	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study to Identify Predictors of Response to Duloxetine in Breast Cancer Patients With Chronic Pain
• Actual Study Start Date: Oct 30, 2013
• Actual Primary Completion Date: Jun 28, 2019
• Actual Study Completion Date: Jun 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 (Patients with pain, duloxetine) Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.	Drug: 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.; Other Names: Cymbalta
No Intervention: Arm 2 (Patients without pain -- control) Patient reported pain and symptoms assessment for comparison at baseline.

Outcome Measures

Primary Outcome Measures

1. Change in Patient-reported Worst Pain Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

   Worst pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory. Baseline: Mean worst pain for all individual patients in arm 1 (intervention) and arm 2 (control) 5 weeks: Mean worst pain for all individual patients in arm 1 (intervention) Range of pain score 0-10 (0=no pain; 10=worst pain)

Secondary Outcome Measures

1. Change in Patient-reported Average Pain Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

   Average pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory. Baseline: Mean average pain for all individual patients in arm 1 (intervention) and arm 2 (control) 5 weeks: Mean average pain for all individual patients in arm 1 (intervention) Range of pain score 0-10 (0=no pain; 10=worst pain)

2. Change in Pain Interference Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

   Pain interference will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory. Baseline: Mean pain interference for all individual patients in arm 1 (intervention) 5 weeks: Mean pain interference for all individual patients in arm 1 (intervention) Range of pain interference score 0-10 (0=no interference; 10=worst interference)

3. Change in Number of Sites of Pain Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

   Number of sites of pain will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map. Baseline: Mean number of sites of pain for all individual patients in arm 1 (intervention) 5 weeks: Mean number of sites of pain for all individual patients in arm 1 (intervention) Range of number of sites of pain 0-35 (0=no pain; 35=every pre-defined body site has pain)

4. Change in Fibromyalgia Symptom Severity Score Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

   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. Baseline: Mean Fibromyalgia Symptom Severity Score for all individual patients in arm 1 (intervention) 5 weeks: Mean Fibromyalgia Symptom Severity Score for all individual patients in arm 1 (intervention) Range of Fibromyalgia Symptom Severity Score 0-12 (0=not consistent with fibromyalgia; 12=most consistent with fibromyalgia)

5. Change in PainDETECT Score Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

   PainDETECT score will be assessed at baseline and 5 weeks for each individual patient using the PainDETECT questionnaire. Baseline: Mean PainDETECT score for all individual patients in arm 1 (intervention) 5 weeks: Mean PainDETECT score for all individual patients in arm 1 (intervention) Range of PainDETECT score -1-38 (-1=no neuropathic pain; 38=most consistent with neuropathic pain)

6. Change in Neuropathy Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

   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. Baseline: Mean neuropathy score for all individual patients in arm 1 (intervention) 5 weeks: Mean neuropathy score for all individual patients in arm 1 (intervention) Range of neuropathy score 0-44 (0=no neuropathy; 44=most consistent with neuropathy)

7. Change in Fatigue Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

   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. Baseline: Mean fatigue T score for all individual patients in arm 1 (intervention) 5 weeks: Mean fatigue T score for all individual patients in arm 1 (intervention) Average fatigue T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=more fatigue)

8. Change in Sleep Disturbance Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

   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. Baseline: Mean sleep disturbance T score for all individual patients in arm 1 (intervention) 5 weeks: Mean sleep disturbance T score for all individual patients in arm 1 (intervention) Average sleep disturbance T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=more sleep disturbance)

9. Change in Physical Function Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

   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. Baseline: Mean physical function T score for all individual patients in arm 1 (intervention) 5 weeks: Mean physical function T score for all individual patients in arm 1 (intervention) Average physical function T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=better physical function)

10. Change in Anxiety Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

    Anxiety will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale. Baseline: Mean anxiety score for all individual patients in arm 1 (intervention) 5 weeks: Mean anxiety score for all individual patients in arm 1 (intervention) Range of anxiety score 0-21 (0=no anxiety, 21=maximum anxiety)

11. Change in Depression Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

    Depression will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale. Baseline: Mean depression score for all individual patients in arm 1 (intervention) 5 weeks: Mean depression score for all individual patients in arm 1 (intervention) Range of depression score 0-21 (0=no depression, 21=maximum depression)

12. Change in Cognitive Difficulties - Language Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

    Cognitive Difficulties - Language will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire. Baseline: Mean language score for all individual patients in arm 1 (intervention) 5 weeks: Mean language score for all individual patients in arm 1 (intervention) Range of language score 0-40 (0=no language difficulties, 40=maximum language difficulties)

13. Change in Cognitive Difficulties - Visual-Perceptual Ability Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

    Cognitive Difficulties - Visual-Perceptual Ability will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire. Baseline: Mean visual-perceptual ability score for all individual patients in arm 1 (intervention) 5 weeks: Mean visual-perceptual ability score for all individual patients in arm 1 (intervention) Range of visual-perceptual ability score 0-30 (0=no visual-perceptual difficulties, 30=maximum visual-perceptual difficulties)

14. Change in Cognitive Difficulties - Verbal Memory Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

    Cognitive Difficulties - Verbal Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire. Baseline: Mean verbal memory score for all individual patients in arm 1 (intervention) 5 weeks: Mean verbal memory score for all individual patients in arm 1 (intervention) Range of verbal memory score 0-40 (0=no verbal memory difficulties, 40=maximum verbal memory difficulties)

15. Change in Cognitive Difficulties - Visual-Spatial Memory Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

    Cognitive Difficulties - Visual-Spatial Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire. Baseline: Mean visual-spatial memory score for all individual patients in arm 1 (intervention) 5 weeks: Mean visual-spatial memory score for all individual patients in arm 1 (intervention) Range of visual-spatial memory score 0-40 (0=no visual-spatial memory difficulties, 40=maximum visual-spatial memory difficulties)

16. Change in Cognitive Difficulties - Attention/Concentration Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

    Cognitive Difficulties - Attention/Concentration will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire. Baseline: Mean attention/concentration score for all individual patients in arm 1 (intervention) 5 weeks: Mean attention/concentration score for all individual patients in arm 1 (intervention) Range of attention/concentration score 0-40 (0=no attention/concentration difficulties, 40=maximum attention/concentration difficulties)

17. Change in Objectively Assessed Pain Sensitivity Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

    Pain sensitivity will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing to assess pressure pain threshold (Pain50). Baseline: Mean Pain50 for all individual patients in arm 1 (intervention) and arm 2 (control) 5 weeks: Mean Pain50 for all individual patients in arm 1 (intervention) Range of Pain50 score: 0-10 kg/cm2 (higher number reflects higher pain threshold or lower pain sensitivity)

18. Change in Objectively Assessed Conditioned Pain Modulation Between Baseline and 5 Weeks of Treatment With Duloxetine [5 weeks]

    Conditioned pain modulation (CPM) will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing Baseline: Mean CPM for all individual patients in arm 1 (intervention) and arm 2 (control) 5 weeks: Mean CPM for all individual patients in arm 1 (intervention) Range of CPM score: -60 to +60 (more positive values reflect more impaired CPM)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Female patients at least 25 years of age

2. Diagnosis of stage 0-III breast cancer within 12 years prior to enrollment. All indicated surgery, chemotherapy, and/or radiation therapy must have been completed at least 12 weeks prior to enrollment. Concomitant endocrine therapy and targeted therapies such as palbociclib, pertuzumab, and trastuzumab are permitted.

3. Pain that developed or worsened since breast cancer diagnosis and is not due to identifiable traumatic event or fracture

4. Patient-reported worst pain score between 5 and 10 (inclusive) on a 0-10 scale (assessed verbally)

5. Female patients must be at least 1 year postmenopausal or surgically sterile; or must agree to use a medically acceptable form of contraception

6. Willing to withdraw from selective serotonin reuptake inhibitors (SSRI) and tricyclic antidepressants (TCA) prior to treatment initiation

7. Patients who are currently taking non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, meloxicam, gabapentin, pregabalin) and/or opioid pain medications must remain on a stable dosage throughout the duration of the study

8. Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

1. Prior use of duloxetine or milnacipran.

2. Prior or current use of venlafaxine specifically for treatment of pain (prior or current use for treatment of other indications, such as hot flashes, is permitted, although cases currently taking venlafaxine must discontinue use prior to study treatment initiation)

3. Patients must not be taking any contraindicated medications listed on the duloxetine package insert including the following: phenothiazines, propafenone, flecainide, linezolid, or anticoagulation medication (e.g., heparin, warfarin, or direct oral anticoagulants); treatment with monoamine oxidase inhibitor within 14 days prior to registration.

4. Thumbnail abnormalities on either hand (such as due to chemotherapy or trauma, or artificial nails) that are likely to alter pain perception during testing

5. Peripheral sensory neuropathy at the thumbs bilaterally that interferes with function and/or activities of daily living

6. Significant risk of suicide based on the Investigator's judgment

7. History or behavior that would, in the Investigator's judgment, prohibit compliance for the duration of the study.

8. History of alcohol or other substance abuse or dependence within the year prior to registration

9. Known chronic liver disease, end stage renal disease, or creatinine clearance <30 mL/min as defined by Cockcroft-Gault equation

10. Uncontrolled narrow-angle glaucoma.

11. Clinically significant coagulation disorder

12. History of seizure disorder

13. Pregnant or breast-feeding. Urine pregnancy test will be assessed at the baseline visit in women of child-bearing potential with chronic pain.

14. Unable to take oral medications or any medical condition that would interfere with the absorption of study medication capsules.

15. Currently taking SSRI, serotonin-norepinephrine reuptake inhibitor (SNRI), or TCA regimen (including Wellbutrin) for treatment of major depressive disorder or generalized anxiety disorder (without approval and involvement of the patient's treating psychiatrist to taper cases off these medications prior to study treatment).

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan	United States	48103
2	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• University of Michigan Rogel Cancer Center
• American Cancer Society, Inc.

Investigators

• Principal Investigator: Lynn Henry, MD, PhD, University of Michigan

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 13, 2020

More Information

Publications

None provided.

• Responsible Party: University of Michigan Rogel Cancer Center
• ClinicalTrials.gov Identifier: NCT01912612
• Other Study ID Numbers: UMCC 2013.044; HUM00075181; HCI94979
• First Posted: Jul 31, 2013
• Last Update Posted: Aug 6, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by University of Michigan Rogel Cancer Center: Breast cancer; Pain sensitivity
• Additional relevant MeSH terms: Chronic Pain; Duloxetine Hydrochloride

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)	Arm 3 - Placebo (Withdrawn)
Arm/Group Description	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.	Surveys administered at baseline only.	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.
Period Title: Overall Study
STARTED	36	40	3
COMPLETED	31	40	0
NOT COMPLETED	5	0	3

Baseline Characteristics

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)	Total
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.	Total of all reporting groups
Overall Participants	35	40	75
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	55	54	55
Sex: Female, Male (Count of Participants)
Female	35 100%	40 100%	75 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	35 100%	40 100%	75 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 2.9%	0 0%	1 1.3%
Native Hawaiian or Other Pacific Islander	2 5.7%	0 0%	2 2.7%
Black or African American	2 5.7%	2 5%	4 5.3%
White	30 85.7%	37 92.5%	67 89.3%
More than one race	0 0%	1 2.5%	1 1.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	35 100%	40 100%	78 104%

Outcome Measures

1. Primary Outcome

Title	Change in Patient-reported Worst Pain Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	Worst pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory. Baseline: Mean worst pain for all individual patients in arm 1 (intervention) and arm 2 (control) 5 weeks: Mean worst pain for all individual patients in arm 1 (intervention) Range of pain score 0-10 (0=no pain; 10=worst pain)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	35	40
Baseline	6.54 (1.868)	0.25 (0.494)
5 weeks	4.06 (2.744)

2. Secondary Outcome

Title	Change in Patient-reported Average Pain Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	Average pain will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory. Baseline: Mean average pain for all individual patients in arm 1 (intervention) and arm 2 (control) 5 weeks: Mean average pain for all individual patients in arm 1 (intervention) Range of pain score 0-10 (0=no pain; 10=worst pain)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	35	40
Baseline	4.86 (2.088)	0.15 (0.362)
5 week timepoint	3.10 (2.271)

3. Secondary Outcome

Title	Change in Pain Interference Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	Pain interference will be assessed at baseline and 5 weeks for each individual patient using the Brief Pain Inventory. Baseline: Mean pain interference for all individual patients in arm 1 (intervention) 5 weeks: Mean pain interference for all individual patients in arm 1 (intervention) Range of pain interference score 0-10 (0=no interference; 10=worst interference)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	34	40
Baseline	4.91 (2.09)	0.03 (0.74)
5 week timepoint	2.30 (2.33)

4. Secondary Outcome

Title	Change in Number of Sites of Pain Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	Number of sites of pain will be assessed at baseline and 5 weeks for each individual patient using the Michigan Body Map. Baseline: Mean number of sites of pain for all individual patients in arm 1 (intervention) 5 weeks: Mean number of sites of pain for all individual patients in arm 1 (intervention) Range of number of sites of pain 0-35 (0=no pain; 35=every pre-defined body site has pain)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	35	40
Baseline	9.63	0.52
5 week timepoint	7.90

5. Secondary Outcome

Title	Change in Fibromyalgia Symptom Severity Score Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	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. Baseline: Mean Fibromyalgia Symptom Severity Score for all individual patients in arm 1 (intervention) 5 weeks: Mean Fibromyalgia Symptom Severity Score for all individual patients in arm 1 (intervention) Range of Fibromyalgia Symptom Severity Score 0-12 (0=not consistent with fibromyalgia; 12=most consistent with fibromyalgia)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	34	40
Baseline	5.35 (2.13)	1.68 (1.37)
week 5 timepoint	4.90 (2.44)

6. Secondary Outcome

Title	Change in PainDETECT Score Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	PainDETECT score will be assessed at baseline and 5 weeks for each individual patient using the PainDETECT questionnaire. Baseline: Mean PainDETECT score for all individual patients in arm 1 (intervention) 5 weeks: Mean PainDETECT score for all individual patients in arm 1 (intervention) Range of PainDETECT score -1-38 (-1=no neuropathic pain; 38=most consistent with neuropathic pain)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	34	40
Baseline	11.44 (8.39)	1.13 (2.02)
week 5 timepoint	8.54 (8.72)

7. Secondary Outcome

Title	Change in Neuropathy Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	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. Baseline: Mean neuropathy score for all individual patients in arm 1 (intervention) 5 weeks: Mean neuropathy score for all individual patients in arm 1 (intervention) Range of neuropathy score 0-44 (0=no neuropathy; 44=most consistent with neuropathy)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	34	39
Baseline	14.09 (8.85)	1.44 (1.67)
week 5 timepoint	9.10 (8.77)

8. Secondary Outcome

Title	Change in Fatigue Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	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. Baseline: Mean fatigue T score for all individual patients in arm 1 (intervention) 5 weeks: Mean fatigue T score for all individual patients in arm 1 (intervention) Average fatigue T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=more fatigue)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	35	40
Baseline	56.79 (7.86)	45.63 (5.53)
week 5 timepoint	54.51 (7.84)

9. Secondary Outcome

Title	Change in Sleep Disturbance Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	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. Baseline: Mean sleep disturbance T score for all individual patients in arm 1 (intervention) 5 weeks: Mean sleep disturbance T score for all individual patients in arm 1 (intervention) Average sleep disturbance T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=more sleep disturbance)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	35	40
Baseline	57.44 (8.25)	43.91 (7.99)
week 5 timepoint	53.85 (8.86)

10. Secondary Outcome

Title	Change in Physical Function Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	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. Baseline: Mean physical function T score for all individual patients in arm 1 (intervention) 5 weeks: Mean physical function T score for all individual patients in arm 1 (intervention) Average physical function T score for the reference population of patients with cancer is 50.0, with standard deviation of 10.0 (higher score=better physical function)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

Only patients with pain were analyzed at week 5. Patients who discontinued study treatment early (n=4) have no data available for week 5.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	35	40
Baseline	41.96 (5.58)	56.60 (5.74)
week 5 timepoint	44.03 (6.13)

11. Secondary Outcome

Title	Change in Anxiety Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	Anxiety will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale. Baseline: Mean anxiety score for all individual patients in arm 1 (intervention) 5 weeks: Mean anxiety score for all individual patients in arm 1 (intervention) Range of anxiety score 0-21 (0=no anxiety, 21=maximum anxiety)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	34	40
Baseline	6.97 (4.00)	3.90 (2.91)
week 4 timepoint	5.03 (3.15)

12. Secondary Outcome

Title	Change in Depression Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	Depression will be assessed at baseline and 5 weeks for each individual patient using the Hospital Anxiety and Depression Scale. Baseline: Mean depression score for all individual patients in arm 1 (intervention) 5 weeks: Mean depression score for all individual patients in arm 1 (intervention) Range of depression score 0-21 (0=no depression, 21=maximum depression)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	34	39
Baseline	5.85 (3.38)	1.46 (1.95)
week 5 timepoint	4.23 (3.96)

13. Secondary Outcome

Title	Change in Cognitive Difficulties - Language Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	Cognitive Difficulties - Language will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire. Baseline: Mean language score for all individual patients in arm 1 (intervention) 5 weeks: Mean language score for all individual patients in arm 1 (intervention) Range of language score 0-40 (0=no language difficulties, 40=maximum language difficulties)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	35	40
Baseline	15.43 (4.51)	12.42 (3.40)
week 5 timepoint	14.83 (3.57)

14. Secondary Outcome

Title	Change in Cognitive Difficulties - Visual-Perceptual Ability Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	Cognitive Difficulties - Visual-Perceptual Ability will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire. Baseline: Mean visual-perceptual ability score for all individual patients in arm 1 (intervention) 5 weeks: Mean visual-perceptual ability score for all individual patients in arm 1 (intervention) Range of visual-perceptual ability score 0-30 (0=no visual-perceptual difficulties, 30=maximum visual-perceptual difficulties)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	34	39
Baseline	10.79 (3.17)	8.62 (3.39)
week 5 timepoint	10.33 (2.70)

15. Secondary Outcome

Title	Change in Cognitive Difficulties - Verbal Memory Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	Cognitive Difficulties - Verbal Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire. Baseline: Mean verbal memory score for all individual patients in arm 1 (intervention) 5 weeks: Mean verbal memory score for all individual patients in arm 1 (intervention) Range of verbal memory score 0-40 (0=no verbal memory difficulties, 40=maximum verbal memory difficulties)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	34	39
Baseline	17.15 (4.57)	13.97 (4.36)
week 5 timepoint	16.90 (3.83)

16. Secondary Outcome

Title	Change in Cognitive Difficulties - Visual-Spatial Memory Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	Cognitive Difficulties - Visual-Spatial Memory will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire. Baseline: Mean visual-spatial memory score for all individual patients in arm 1 (intervention) 5 weeks: Mean visual-spatial memory score for all individual patients in arm 1 (intervention) Range of visual-spatial memory score 0-40 (0=no visual-spatial memory difficulties, 40=maximum visual-spatial memory difficulties)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	35	39
Baseline	14.43 (3.07)	13.03 (4.84)
week 5 timepoint	14.53 (3.64)

17. Secondary Outcome

Title	Change in Cognitive Difficulties - Attention/Concentration Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	Cognitive Difficulties - Attention/Concentration will be assessed at baseline and 5 weeks for each individual patient using the Multiple Ability Self-Report Questionnaire. Baseline: Mean attention/concentration score for all individual patients in arm 1 (intervention) 5 weeks: Mean attention/concentration score for all individual patients in arm 1 (intervention) Range of attention/concentration score 0-40 (0=no attention/concentration difficulties, 40=maximum attention/concentration difficulties)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	34	39
Baseline	17.26 (3.43)	14.10 (3.60)
week 5 timepoint	15.83 (3.49)

18. Secondary Outcome

Title	Change in Objectively Assessed Pain Sensitivity Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	Pain sensitivity will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing to assess pressure pain threshold (Pain50). Baseline: Mean Pain50 for all individual patients in arm 1 (intervention) and arm 2 (control) 5 weeks: Mean Pain50 for all individual patients in arm 1 (intervention) Range of Pain50 score: 0-10 kg/cm2 (higher number reflects higher pain threshold or lower pain sensitivity)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	35	40
Baseline	3.20 (1.37)	4.06 (1.40)
week 5 timepoint	3.30 (1.38)

19. Secondary Outcome

Title	Change in Objectively Assessed Conditioned Pain Modulation Between Baseline and 5 Weeks of Treatment With Duloxetine
Description	Conditioned pain modulation (CPM) will be assessed at baseline and 5 weeks for each individual patient using quantitative sensory testing Baseline: Mean CPM for all individual patients in arm 1 (intervention) and arm 2 (control) 5 weeks: Mean CPM for all individual patients in arm 1 (intervention) Range of CPM score: -60 to +60 (more positive values reflect more impaired CPM)
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Arm 1 (Patients With Pain)	Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.	Patient reported pain and symptoms assessment for comparison at baseline.
Measure Participants	34	38
Baseline	9.68 (16.47)	7.97 (15.32)
week 5 timepoint	11.93 (12.76)

Adverse Events

Time Frame	Adverse Event (AE) data were collected from date of study drug administration until 14 days after completion of study drug
Arm/Group Title	Arm 1 (Patients With Pain)		Arm 2 (Patients Without Pain -- Control)
Arm/Group Description	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.		Patient reported pain and symptoms assessment for comparison at baseline.
All Cause Mortality
	Arm 1 (Patients With Pain)		Arm 2 (Patients Without Pain -- Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/40 (0%)
Serious Adverse Events
	Arm 1 (Patients With Pain)		Arm 2 (Patients Without Pain -- Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/35 (2.9%)		0/40 (0%)
Cardiac disorders
congestive heart failure	1/35 (2.9%)	1	0/40 (0%)	0
Other (Not Including Serious) Adverse Events
	Arm 1 (Patients With Pain)		Arm 2 (Patients Without Pain -- Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/35 (28.6%)		0/40 (0%)
Gastrointestinal disorders
nausea	4/35 (11.4%)	4	0/40 (0%)	0
General disorders
fatigue	2/35 (5.7%)	2	0/40 (0%)	0
Nervous system disorders
Dizziness	4/35 (11.4%)	4	0/40 (0%)	0
headache	3/35 (8.6%)	3	0/40 (0%)	0
Psychiatric disorders
insomnia	3/35 (8.6%)	3	0/40 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.