Pregabalin in Treating Women With Hot Flashes
RATIONALE: Pregabalin may help relieve hot flashes in women who do not wish to take estrogen therapy for fear of increased risk of breast cancer. It is not yet known which dose of pregabalin may be more effective in treating hot flashes.
PURPOSE: This randomized phase III trial is studying the side effects of two doses of pregabalin and to see how well it works compared with a placebo in treating women with hot flashes.
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of Pregabalin for Alleviating Hot Flashes|
- Hot flash score after 6 weeks of treatment [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Mood and hot flash-related daily interference on activities [ Designated as safety issue: No ]
- Comparison of 75 mg of pregabalin vs placebo [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
Experimental: Arm II
Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
Placebo Comparator: Arm III
Patients receive oral placebo twice daily for 6 weeks.
- To evaluate the efficacy of 150 mg of pregabalin versus placebo on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer.
- To evaluate the side effect profile of different doses of pregabalin in these patients.
- To evaluate the effect of 150 mg of pregabalin versus placebo on the secondary outcome of interference of activities from hot flashes in these patients.
- To evaluate the efficacy and side effect profile of 75 mg of pregabalin versus placebo in these patients.
OUTLINE: Patients are stratified according to age (18-49 years vs ≥ 50 years); selective estrogen-receptor modulator (i.e., tamoxifen or raloxifene) or aromatase inhibitor use (yes vs no); duration of hot flashes (< 9 months vs ≥ 9 months); and frequency of hot flashes per 24-hour period (4-9 vs ≥ 10). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
- Arm II: Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
- Arm III: Patients receive oral placebo twice daily for 6 weeks. Treatment in all arms continues in the absence of unacceptable toxicity.
Patients complete Hot Flash Diaries at baseline and once daily during treatment and the Symptom Experience Diary at baseline and once weekly during treatment. Patients also complete the Profile of Mood States and the Hot Flash Related Daily Interference Scale questionnaires at baseline and after completion of study treatment.