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

NCT01028352 | Completed Results DMC

• 2 other identifiers: UMCC 2008.062HUM00022455
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (1)

• Decrease in Average Pain With 8 Weeks of Duloxetine Therapy. (Sustained)

  Baseline, 2, 4 , 6 and 8 weeks

Study Arms (1)

Duloxetine

OTHER

Drug: Duloxetine

Interventions

Duloxetine DRUG

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.

Also known as: Cymbalta

Duloxetine

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Inventory;
• ECOG performance status 0-2;
• Willing and able to sign an informed consent document.

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0944, United States

Location

Related Publications (1)

• Henry NL, Banerjee M, Wicha M, Van Poznak C, Smerage JB, Schott AF, Griggs JJ, Hayes DF. Pilot study of duloxetine for treatment of aromatase inhibitor-associated musculoskeletal symptoms. Cancer. 2011 Dec 15;117(24):5469-75. doi: 10.1002/cncr.26230. Epub 2011 Jun 20.

  PMID: 21692065 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Norah L. Henry
• Organization: University of Michigan Comprehensive Cancer Center

norahh@umich.edu

734-936-4991

Study Officials

• Norah L Henry, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: October 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: October 1, 2011
• Last Updated: August 8, 2013
• Results First Posted: August 17, 2012

Record last verified: 2013-07

Locations

US (1)