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Phase III Randomized Study of Gabapentin With Versus Without Antidepressants for the Management of Hot Flashes in Women With a History of Breast Cancer or a Concern About Taking Hormonal Therapy Due to a Fear of Developing Breast Cancer
Alternate Title Gabapentin With or Without Antidepressants in Treating Hot Flashes in Women Who Have Had Breast Cancer or Have Concerns About Taking Hormone Therapy
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
Other
Expected Enrollment A total of 110 patients (55 per treatment arm) will be accrued for this study within 2 years. Outcomes Primary Outcome(s)Hot flash reduction by diary record at 4 weeks
Toxicity by questionnaires at 4 weeks
Outline This is a randomized, multicenter study. Patients are stratified according to duration of hot flash symptoms (< 9 months vs ≥ 9 months), average frequency of hot flashes per day (2-3 vs 4-9 vs ≥ 10), and antidepressant currently being used (venlafaxine vs paroxetine vs other). Patients are randomized to 1 of 2 treatment arms.
Patients in both arms complete a hot flash diary at baseline and then daily during study treatment. Quality of life is assessed at baseline and then weekly during study treatment. Published ResultsLoprinzi CL, Kugler JW, Barton DL, et al.: Phase III trial of gabapentin alone or in conjunction with an antidepressant in the management of hot flashes in women who have inadequate control with an antidepressant alone: NCCTG N03C5. J Clin Oncol 25 (3): 308-12, 2007.[PUBMED Abstract] Loprinzi CL, Kugler JW, Barton DL, et al.: Phase III randomized trial to evaluate the use of gabapentin alone vs with continuing an antidepressant in women failing an antidepressant for the treatment of hot flashes: North Central Cancer Treatment Group study N03C5. [Abstract] J Clin Oncol 24 (Suppl 18): A-526, 9s, 2006. Trial Lead Organizations North Central Cancer Treatment Group
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. |
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