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Pain | Mechanistic Study of Duloxetine Versus Placebo in Breast Cancer Patients With Chronic Pain

Pain research study

What is the primary objective of this study?

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 versus placebo, 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.

Who is eligible to participate?

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 pablociclib, 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 and tricyclic antidepressants prior to treatment initiation 7. Patients who are currently taking non-steroidal anti-inflammatory drugs 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 use of venlafaxine specifically for treatment of pain (prior use for treatment of other indications, such as hot flashes, is permitted) 3. Patients must not be taking any contraindicated medications listed on the duloxetine package insert including the following: phenothiazines, propafenone, flecanide, linezolid, or anticoagulation medication (e.g., heparin, warfarin); treatment with MAO 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, SNRI, or TCA regimen for treatment of major depressive disorder or generalized anxiety disorder (without approval and involvement of the patient's treating psychiatrist). 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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:DuloxetineSubjects 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Arm 1Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.

Study Status

Recruiting

Start Date: August 2013

Completed Date: March 2023

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Change in patient-reported pain between baseline and 5 weeks of treatment with duloxetine

Secondary Outcome: Change in objectively assessed pain sensitivity between baseline and 5 weeks of treatment with duloxetine

Study sponsors, principal investigator, and references

Principal Investigator: Norah L Henry, MD, PhD

Lead Sponsor: University of Utah

Collaborator: American Cancer Society, Inc.

More information:https://clinicaltrials.gov/show/NCT01912612

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