drugset / Trial / NCT00028574
Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
Phase 3
Completed
223 enrolled
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI) · collab
RandomizedParallel-groupTriple-blindSupportive care
Summary
RATIONALE: Gabapentin may be effective in relieving hot flashes in men who have prostate cancer. It is not yet known which regimen of gabapentin is most effective in treating hot flashes. PURPOSE: Randomized phase III trial to compare different regimens of gabapentin in treating men who have prostate cancer.
Timeline
- Start
- 2001-12
- Primary completion
- 2006-12
- Completion
- 2007-04
Publications
- Results Loprinzi CL, Dueck AC, Khoyratty BS, Barton DL, Jafar S, Rowland KM Jr, Atherton PJ, Marsa GW, Knutson WH, Bearden JD 3rd, Kottschade L, Fitch TR. A phase III randomized, double-blind, placebo-controlled trial of gabapentin in the management of hot flashes in men (N00CB). Ann Oncol. 2009 Mar;20(3):542-9. doi: 10.1093/annonc/mdn644. Epub 2009 Jan 6.
- Results Moraska AR, Atherton PJ, Szydlo DW, Barton DL, Stella PJ, Rowland KM Jr, Schaefer PL, Krook J, Bearden JD, Loprinzi CL. Gabapentin for the management of hot flashes in prostate cancer survivors: a longitudinal continuation Study-NCCTG Trial N00CB. J Support Oncol. 2010 May-Jun;8(3):128-32.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gabapentin | Small molecule | 300 mg | Oral |
| Comparator | Gabapentin | Small molecule | 600 mg | Oral |
| Comparator | Gabapentin | Small molecule | 900 mg | Oral |