UMCC 2008.62: Prospective Pilot Study Evaluating the Use of Duloxetine for Treatment of Aromatase Inhibitor-associated Musculoskeletal Symptoms in Breast Cancer Patients
Aromatase inhibitor (AI) therapy is commonly used for treatment of postmenopausal women with
hormone receptor-positive breast cancer. The most common toxicities are arthralgias and
myalgias, which can be difficult to manage and necessitate discontinuation of therapy in up
to 10% of patients. One potential interventional approach is with a pharmaceutical agent
such as duloxetine, which has been shown to be effective for treatment of other types of
chronic pain, including fibromyalgia and diabetic neuropathic pain.
The primary objective of this pilot study is to determine the proportion of breast cancer
patients with AI-associated musculoskeletal symptoms who experience a 30% reduction in
average pain score from baseline to 8 weeks due to duloxetine treatment. Participants will
be treated with duloxetine for 8 weeks. Questionnaires to evaluate pain, functional status,
depression, menopausal symptoms, and sleep difficulties will be administered at baseline and
after 2, 4, 6, and 8 weeks of therapy. In addition, 10 milliliters blood of will be drawn
from the subjects at baseline for future pharmacogenetic evaluation. If the results of this
pilot study suggest that the efficacy of duloxetine therapy is greater than that expected
from placebo based on historical controls, then these data will be used to design future
prospective, placebo-controlled, randomized trials of treatment with duloxetine in this
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Patients Who Experience 30% Reduction in Average Pain Score From Baseline to 8 Weeks Due to Duloxetine Therapy.
Subjects were considered evaluable if they met all eligibility criteria and took at least one dose of duloxetine. Average pain was measured using Wisconsin Brief Pain Inventory Questionnaire.(BPI) The BPI is a 17-item patient self-rating scale that assessed sensory & reactive components of pain. The BPI uses 0 to 10 numeric rating scales for item rating.Since pain can be variable,the BPI asks patients to rate pain at completing questionnaire, and also at its worst, least, and average over the previous 24 hours. The primary endpoint is based on the 24-hour avg pain as reported on BPI.
Norah L Henry, MD, PhD
University of Michigan
United States: Institutional Review Board
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|