MedTrace Logo

Study to Assess Effect of 8 Wks of Duloxetine Therapy on Breast Cancer Patients With Aromatase-Inhibitor Associated Pain

NCT01028352 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2013-08-08

Study results available
· View outcomes & findings →

Summary

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.

Conditions

Interventions

DRUG

Duloxetine

Patients will be treated with open-label duloxetine: * 30 mg daily x 7 days, then * 60 mg daily x 3 weeks, then * If a patient believes she has experienced a sufficient reduction in pain after 4 weeks of therapy, she will continue taking 60 mg daily for weeks 5-8 * If a patient does not believe she has experienced a sufficient reduction in pain after 4 weeks of therapy, she will have the option of increasing the dose to 60 mg twice daily for weeks 5-8. * After completion of 8 weeks of therapy, patients who wish to discontinue therapy will taper off the drug over 1 week (50% decrease for 4 days, then additional 50% decrease for 3 days). Patients may continue therapy off-study at the discretion of their treating physician.

Sponsors & Collaborators

Principal Investigators

  • Norah L Henry, MD, PhD · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-11-30
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01028352 on ClinicalTrials.gov