Study to Assess Effect of 8 Wks of Duloxetine Therapy on Breast Cancer Patients With Aromatase-Inhibitor Associated Pain
| Status: | Archived |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2008 |
| End Date: | June 2015 |
UMCC 2008.62: Prospective Pilot Study Evaluating the Use of Duloxetine for Treatment of Aromatase Inhibitor-associated Musculoskeletal Symptoms in Breast Cancer Patients
Many women with breast cancer who are treated with aromatase inhibitor medications develop
aches and pains during treatment, and some develop numbness and tingling in their hands and
feet. Some examples of aromatase inhibitor medications include anastrozole (Arimidex),
exemestane (Aromasin), and letrozole (Femara). Frequently, pain medications do not work very
well to relieve the pain. Duloxetine (Cymbalta) is a medication that was originally
developed to treat depression. It has also been found to relieve pain that occurs in people
with diabetes, fibromyalgia, arthritis, and other painful conditions. In this study we are
testing to see if duloxetine will help treat the pain that can occur in women treated with
aromatase inhibitors.
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
patient population.
We found this trial at
1
site
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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