Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anxiety Disorder; Breast Cancer; Depression; Hot Flashes; Quality of Life
Intervention: gabapentin (Drug); hot flashes attenuation (Procedure); psychosocial assessment and care (Procedure); quality-of-life assessment (Procedure)
Phase: N/A
Status: Active, not recruiting
Sponsored by: James P. Wilmot Cancer Center Official(s) and/or principal investigator(s):
Kishan J. Pandya, MD, Study Chair, Affiliation: James P. Wilmot Cancer Center
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.
Clinical Details
Official title: Control of Vasomotor Symptoms in Women Treated for Breast Cancer
Study design: Supportive Care, Randomized, Open Label, Placebo Control
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
MBCCOP - Gulf Coast, Mobile, Alabama 36688, United States
CCOP - Greater Phoenix, Phoenix, Arizona 85006-2726, United States
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado 80224, United States
MBCCOP - Hawaii, Honolulu, Hawaii 96813, United States
CCOP - Central Illinois, Decatur, Illinois 62526, United States
CCOP - Wichita, Wichita, Kansas 67214-3882, United States
CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States
CCOP - Northern New Jersey, Hackensack, New Jersey 07601, United States
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
CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina 27104-4241, United States
CCOP - Columbus, Columbus, Ohio 43206, United States
CCOP - Dayton, Dayton, Ohio 45429, United States
CCOP - Northwest, Tacoma, Washington 98405-0986, United States
CCOP - Virginia Mason Research Center, Seattle, Washington 98101, United States
CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin 54449, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 2001
Last updated: December 15, 2007
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