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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00022074
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 15, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorder Breast Cancer Depression Hot Flashes Drug: gabapentin Procedure: quality-of-life assessment Not Applicable

Detailed Description:


  • 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  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Control of Vasomotor Symptoms in Women Treated for Breast Cancer
Study Start Date : July 2001
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


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

    • Not specified



  • Not specified


  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


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


  • Creatinine no greater than 1.25 times ULN


  • 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


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00022074

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

Publications of Results:
Responsible Party: Gary Morrow, Director, University of Rochester NCORP Research Base, University of Rochester NCORP Research Base Identifier: NCT00022074     History of Changes
Other Study ID Numbers: CDR0000068780
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 15, 2015
Last Verified: October 2015

Keywords provided by Gary Morrow, University of Rochester NCORP Research Base:
stage I breast cancer
stage II breast cancer
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
anxiety disorder
hot flashes

Additional relevant MeSH terms:
Breast Neoplasms
Anxiety Disorders
Hot Flashes
Neoplasms by Site
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mental Disorders
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents