Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
Control of Vasomotor Symptoms in Women Treated for Breast Cancer
3 other identifiers
interventional
N/A
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2001
Longer than P75 for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedFirst Submitted
Initial submission to the registry
August 10, 2001
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedOctober 15, 2015
October 1, 2015
3.9 years
August 10, 2001
October 13, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Gary Morrowlead
- National Cancer Institute (NCI)collaborator
Study Sites (18)
MBCCOP - Gulf Coast
Mobile, Alabama, 36688, United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726, United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, 80224, United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813, United States
CCOP - Central Illinois
Decatur, Illinois, 62526, United States
CCOP - Wichita
Wichita, Kansas, 67214-3882, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601, United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241, United States
CCOP - Columbus
Columbus, Ohio, 43206, United States
CCOP - Dayton
Dayton, Ohio, 45429, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101, United States
CCOP - Northwest
Tacoma, Washington, 98405-0986, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449, United States
Related Publications (1)
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.
PMID: 16139656RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kishan J. Pandya, MD
James P. Wilmot Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, University of Rochester NCORP Research Base
Study Record Dates
First Submitted
August 10, 2001
First Posted
January 27, 2003
Study Start
July 1, 2001
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
October 15, 2015
Record last verified: 2015-10