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	Treatment or Intervention
Anxiety Disorder Breast Cancer Depression Hot Flashes Quality of Life	Drug: gabapentin  Procedure: hot flashes attenuation  Procedure: menopausal symptoms attenuation  Procedure: psychosocial assessment/care  Procedure: quality-of-life assessment  Procedure: supportive care/therapy

Further Study Details: 

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.

Genders Eligible for Study:  Both

Criteria

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

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

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000068780; URCC-U2101; NCI-P01-0183
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022074
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08