Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen

NCT02819921 ↗

Phase 4 Terminated 59 enrolled Seoul National University Hospital Korea Cancer Center Hospital · collab Pfizer · collab Seoul National University Bundang Hospital · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a randomized, placebo-controlled study of desvenlafaxine versus placebo. The purpose of this study is to determine if desvenlafaxine was effective in decreasing the frequency and severity of hot flashes in breast cancer patients taking tamoxifen.

Timeline

Start: 2017-11-10
Primary completion: 2019-03-15
Completion: 2019-06-15

Outcome

Met primary endpoint

Stopped (Enrollment): “Difficulty in Recruiting Research Participants”

paper Both desvenlafaxine arms demonstrated greater HF score reductions compared to placebo: D-50 (2.20 points/week, 95% CI: 0.71, 3.68) and D-100 (2.34 points/week, 95% CI: 0.92, 3.76). PMID 39019875 ↗

Publications

Kim Y, Yeom CW, Lee HJ, Kim JH, Lee KM, Kim TY, Lee HB, Kim H, Im SA, Lee KH, Kim M, Han W, Moon HG, Spiegel D, Hahm BJ, Son KL. Differential effects of desvenlafaxine on hot flashes in women with breast cancer taking tamoxifen: a randomized controlled trial. NPJ Breast Cancer. 2024 Jul 17;10(1):59. doi: 10.1038/s41523-024-00668-w.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Desvenlafaxine	Other / unclassified	50 mg	Oral
Subject	Desvenlafaxine	Other / unclassified	100 mg	Oral