Control of Vasomotor Symptoms in Women Treated for Breast Cancer
N/A
N/A
Female
Anxiety Disorder, Breast Cancer, Depression, Hot Flashes
Trial Information
Control of Vasomotor Symptoms in Women Treated for Breast Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Principal Investigator
Kishan J. Pandya, MD
Investigator Role:
Study Chair
Investigator Affiliation:
James P. Wilmot Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068780
NCT ID:
NCT00022074
Start Date:
July 2001
Completion Date:
June 2005
Related Keywords:
- Anxiety Disorder
- Breast Cancer
- Depression
- Hot Flashes
- 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
- depression
- hot flashes
- Anxiety Disorders
- Breast Neoplasms
- Depression
- Depressive Disorder
- Hot Flashes
Name | Location |
|---|---|
| MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Greater Phoenix | Phoenix, Arizona 85006-2726 |
| CCOP - North Shore University Hospital | Manhasset, New York 11030 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
| CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
| CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
