Mechanistic Study of Duloxetine Versus Placebo in Breast Cancer Patients With Chronic Pain
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|ClinicalTrials.gov Identifier: NCT01912612|
Recruitment Status : Recruiting
First Posted : July 31, 2013
Last Update Posted : September 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Duloxetine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Identify Predictors of Response to Duloxetine in Breast Cancer Patients With Chronic Pain|
|Actual Study Start Date :||August 2013|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2023|
Experimental: Arm 1
Duloxetine 30 mg daily x 1 week, then 60 mg daily x 4 weeks, then 30 mg daily x 2 weeks.
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 Name: Cymbalta
- Change in patient-reported pain between baseline and 5 weeks of treatment with duloxetine [ Time Frame: 5 weeks ]Subjects will be treated with duloxetine for 5 weeks followed by a 2 week taper off the drug. Change in pain between baseline and 5 weeks for each individual patient will be determined.
- Change in objectively assessed pain sensitivity between baseline and 5 weeks of treatment with duloxetine [ Time Frame: 5 weeks ]Subjects will be treated with duloxetine for 5 weeks followed by a 2 week taper off the drug. Change in pain sensitivity between baseline and 5 weeks for each individual patient will be assessed using quantitative sensory testing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912612
|Contact: Amanda Behuninfirstname.lastname@example.org|
|United States, Utah|
|Huntsman Cancer Institute||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Amanda Behunin 801-587-4323 email@example.com|
|Principal Investigator: Norah L Henry, MD, PhD|
|Principal Investigator:||Norah L Henry, MD, PhD||Huntsman Cancer Institute|