Gabapentin For the Control of Hot Flashes in Women With Breast Cancer

NCT00022074 ↗

Completed Gary Morrow National Cancer Institute (NCI) · collab

RandomizedOpen-labelSupportive care

Summary

RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if gabapentin is effective in treating hot flashes. PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer.

Timeline

Start: 2001-07
Primary completion: 2005-06
Completion: 2005-06

Outcome

Met primary endpoint

paper The differences between the groups were significant (p=0.0001 at 4 weeks and p=0.007 at 8 weeks by ANCOVA for overall treatment effect, adjusted for baseline values); PMID 16139656 ↗

paper Gabapentin is effective in the control of hot flashes at a dose of 900 mg/day, but not at a dose of 300 mg/day. PMID 16139656 ↗

Publications

Results Pandya KJ, Morrow GR, Roscoe JA, Zhao H, Hickok JT, Pajon E, Sweeney TJ, Banerjee TK, Flynn PJ. Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebo-controlled trial. Lancet. 2005 Sep 3-9;366(9488):818-24. doi: 10.1016/S0140-6736(05)67215-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gabapentin	Unknown	300 mg	Oral
Subject	Gabapentin	Unknown	900 mg	Oral