|
||||||||||||||||||||||
![]() |
|
|
|
![]() |
Randomized Study of Gabapentin For the Control of Hot Flashes and Other Vasomotor Symptoms in Women With Breast Cancer
Alternate Title Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Patient Characteristics: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
Expected Enrollment A total of 408 patients (136 per arm) will be accrued for this study within 18 months. 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.
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. Published ResultsPandya KJ, Morrow GR, Roscoe JA, et al.: Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebo-controlled trial. Lancet 366 (9488): 818-24, 2005 Sep 3-9.[PUBMED Abstract] Trial Lead Organizations James P. Wilmot Cancer Center at University of Rochester Medical Center
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
![]() |
![]() |
![]() |
![]() |
NCI Home |
Images Version |
Contact Us |
Policies |
Accessibility |
Viewing Files |
FOIA |
Site Help |
Site Map
|
![]() A Service of the National Cancer Institute |
![]() |
![]() |