Gabapentin For the Control of Hot Flashes in Women With Breast Cancer

October 13, 2015 updated by: Gary Morrow

Control of Vasomotor Symptoms in Women Treated for Breast Cancer

RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if gabapentin is effective in treating hot flashes.

PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the effectiveness and side effects of 2 different doses of gabapentin vs placebo for the control of hot flashes and other vasomotor symptoms in women with breast cancer.
  • Compare quality of life, anxiety, and depression in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and duration of hot flash symptoms (less than 9 months vs 9 or more months). Patients are randomized to 1 of 3 arms.

  • Arm I: Patients receive oral placebo 3 times a day.
  • Arm II: Patients receive oral gabapentin at a low dose 3 times a day.
  • Arm III: Patients receive oral gabapentin as in arm II for 3 days and then at a high dose 3 times a day.

Treatment on all arms continues for 8 weeks in the absence of unacceptable toxicity. After week 8, patients may receive open-label gabapentin at the discretion of their physicians.

Hot flashes are assessed at baseline and then during weeks 3 and 7 of the study.

Quality of life, anxiety, and depression are assessed at baseline and then at weeks 4 and 8.

Patients are followed at week 12.

PROJECTED ACCRUAL: A total of 408 patients (136 per arm) will be accrued for this study within 18 months.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36688
        • MBCCOP - Gulf Coast
    • Arizona
      • Phoenix, Arizona, United States, 85006-2726
        • CCOP - Greater Phoenix
      • Scottsdale, Arizona, United States, 85259-5404
        • CCOP - Scottsdale Oncology Program
    • Colorado
      • Denver, Colorado, United States, 80224
        • CCOP - Colorado Cancer Research Program, Incorporated
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
    • Kansas
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
    • Michigan
      • Kalamazoo, Michigan, United States, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • CCOP - Northern New Jersey
    • New York
      • Manhasset, New York, United States, 11030
        • CCOP - North Shore University Hospital
      • Syracuse, New York, United States, 13217
        • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104-4241
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Columbus, Ohio, United States, 43206
        • CCOP - Columbus
      • Dayton, Ohio, United States, 45429
        • CCOP - Dayton
    • Washington
      • Seattle, Washington, United States, 98101
        • CCOP - Virginia Mason Research Center
      • Tacoma, Washington, United States, 98405-0986
        • CCOP - Northwest
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • CCOP - Marshfield Medical Research and Education Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer
  • Experiencing 2 or more hot flashes per day for at least 1 week

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin normal
  • SGOT no greater than 2 times upper limit of normal (ULN)

Renal:

  • Creatinine no greater than 1.25 times ULN

Cardiovascular:

  • No coronary insufficiency
  • No myocardial infarction within the past 3 months
  • No symptomatic cardiac disease
  • No peripheral vascular disease
  • No cerebrovascular disease or stroke
  • No syncope or symptomatic hypotension

Other:

  • No history of allergic or other adverse reaction to gabapentin
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 1 week after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No other concurrent anticonvulsant medication
  • No concurrent clonidine or venlafaxine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gary Morrow

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Kishan J. Pandya, MD, James P. Wilmot Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

August 10, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068780
  • URCC-U2101
  • NCI-P01-0183

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe