8014 Background: Hot flashes are a prominent symptom in breast cancer survivors. Available data demonstrate that both venlafaxine and progestational agents substantially decrease hot flashes. This trial was developed to compare these two agents. Methods: 227 women, reporting at least 14 hot flashes/wk were randomized to venlafaxine (37.5 mg/day for a wk, then 75 mg/d, 109 pts) versus MPA (400 mg IM, 109 pts) versus MPA (500 mg IM q 2 w for 3 doses, 9 pts, arm closed early due to slow initial study accrual), after being stratified for age, tamoxifen use, raloxifene use, and the duration and frequency of hot flash symptoms. Assuming 109 pts per each of the 2 main study arms, this study had 90% power to detect a difference between the two treatments of 1 hot flash per day, or a drop of 16% from baseline, with a 5% Type I error. Results: At this time, data are reported for 185 evaluable pts (81%). All examined pretreatment factors were equally balanced between the two major treatment groups. 90% of participants reported ≥ 4 hot flashes/d while 35% reported ≥ 10 hot flashes/d. At wk 7 (compared to the baseline wk) pts on 400 mg/d MPA, vs those on venlafaxine, had greater reductions in median hot flash frequencies (85% vs 52% reduction, p<0.0001) and reductions in median hot flash scores (88% vs 57% reduction, p<0.0001). 24% of MPA (400 mg/d) pts reported no hot flashes at wk 7, compared to 1% of venlafaxine pts (p<0.0001). Pts on 400 mg/d MPA had less trouble sleeping (p=0.04), less sleepiness (p=0.01), less constipation (p<0.0001), less abnormal sweating (p=0.0001), and less hot flash distress (p<0.0001). Pts on venlafaxine had trends for less trouble with “controlling their feelings” (p=0.06), less “feeling tense” (p=0.07), and less “stress” (p=0.08). Conclusion: A single dose of MPA is well tolerated and relieves hot flashes better than does venlafaxine. No significant financial relationships to disclose.
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