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UMCC 2008.62: Prospective Pilot Study Evaluating the Use of Duloxetine for Treatment of Aromatase Inhibitor-associated Musculoskeletal Symptoms in Breast Cancer Patients

21 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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
patient population.

Inclusion Criteria:

- Female;

- Histologically proven stage 0-III invasive carcinoma of the breast that is ER and/or
PR positive by immunohistochemical staining, who are receiving a standard dose of
aromatase inhibitor (AI) therapy (letrozole 2.5mg once daily or exemestane 25mg once
daily or anastrozole 1mg once daily). Women with oligometastatic disease may be
included at the discretion of the principal investigator. Surgical resection,
chemotherapy, and radiation therapy must have been completed at the time of study
enrollment, with the exception of trastuzumab;

- AI therapy has been ongoing for ≥ 2 weeks and treatment is expected to continue;

- AI-associated musculoskeletal symptoms, defined as:

- Grade 1 or higher musculoskeletal pain that developed or worsened (6 or 7 on
CGICS) during AI therapy or

- Grade 1 or higher sensory neuropathy that developed or worsened (6 or 7 on
CGICS) during AI therapy;

- Average pain of ≥4 on the 11-point Likert scale of question #5 of the Brief Pain

- ECOG performance status 0-2;

- Willing and able to sign an informed consent document.

Exclusion Criteria:

- Known hypersensitivity to duloxetine or any of the inactive ingredients;

- New musculoskeletal pain that is due specifically to fracture or traumatic injury;

- Treatment with monoamine oxidase inhibitors (MAO-I) within 14 days of enrollment;

- Concurrent treatment with phenothiazines (including thioridazine), propafenone,
flecainide, triptans, MAO-Is, SSRIs, SNRIs, or tricyclic antidepressants;

- Currently primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal
ideation, history of bipolar disorder, or seizure disorder;

- Chronic liver disease, end stage renal disease, or creatinine clearance < 30 mL/min
as defined by the Cockroft-Gault equation;

- Uncontrolled narrow-angle glaucoma or clinically significant coagulation disorder;

- Pregnant or breast feeding;

- History of alcohol or other substance abuse or dependence within the year prior to

- Serious or unstable medical condition that could likely lead to hospitalization
during the course of the study or compromise study participation.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Patients Who Experience 30% Reduction in Average Pain Score From Baseline to 8 Weeks Due to Duloxetine Therapy.

Outcome Description:

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.

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Norah L Henry, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:

UMCC 2008.062



Start Date:

October 2008

Completion Date:

June 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752