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Home > "G" Clinical Trials Conditions > Gabapentin For the Control of Hot Flashes in Women With Breast Cancer  Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
For Condition: Breast Cancer,Hot Flashes,Anxiety Disorder,Depression,Quality of Life
Status: No longer recruiting
Sponsor(s): James P. Wilmot Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KishanPandya, Study Chair, James P. Wilmot Cancer Center
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, 80224
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - Dayton
Dayton, Ohio, 45429
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
Additional Information:
Study ID Numbers: CDR0000068780; URCC-U2101,NCI-P01-0183
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022074
Other Quality Of Life Studies:
1. A Phase I Study of Infusional Paclitaxel with the P-Glycoprotein Antagonist PSC 833
2. Risedronate Sodium on Bone in Postmenopausal Women with Hormone-Receptor-Positive Early Breast Cancer
3. Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation
4. Breast Imaging Studies in Women at High Genetic Risk of Breast Cancer: Menstrual Cycle Study
5. Study of the Emotional Needs of Caregivers of Stem Cell Transplantation Patients
Related Studies:
Other Quality of Life Clinical Trials
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Other Kalamazoo Clinical Trials
Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
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