Mechanistic Study of Duloxetine in Breast Cancer Patients With Chronic Pain
Status:
Completed
Trial end date:
2019-06-28
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Lynn Henry University of Michigan Rogel Cancer Center