Gabapentin With or Without Antidepressants in Treating Hot Flashes in Women Who Have Had Breast Cancer or Have Concerns About Taking Hormone Therapy

Summary

RATIONALE: Gabapentin may be effective in relieving hot flashes in women who have had breast cancer or who have concerns about taking hormone therapy to treat hot flashes. It is not yet known whether gabapentin is more effective with or without antidepressants in treating hot flashes. PURPOSE: This randomized phase III trial is studying gabapentin and antidepressants to see how well they work compared to antidepressants alone in treating hot flashes in women who have had breast cancer or who have concerns about taking hormones to treat hot flashes.

Timeline

Start

2004-11

Primary completion

2007-04

Completion

2007-04

Outcome

Missed primary endpoint

paper This study saw no significant additional hot flash reduction from continuation of the antidepressant. PMID 17146104 ↗

Publications

• Results Loprinzi CL, Kugler JW, Barton DL, Dueck AC, Tschetter LK, Nelimark RA, Balcueva EP, Burger KN, Novotny PJ, Carlson MD, Duane SF, Corso SW, Johnson DB, Jaslowski AJ. 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. 2007 Jan 20;25(3):308-12. doi: 10.1200/JCO.2006.07.5390. Epub 2006 Dec 4.
• Results 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.

Drugs

Indications