Gabapentin With or Without Antidepressants in Treating Hot Flashes in Women Who Have Had Breast Cancer or Have Concerns About Taking Hormone Therapy
A Phase III Randomized, 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
3 other identifiers
interventional
118
1 country
162
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Nov 2004
Shorter than P25 for phase_3 breast-cancer
162 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
First Submitted
Initial submission to the registry
July 8, 2004
CompletedFirst Posted
Study publicly available on registry
July 12, 2004
CompletedStudy Start
First participant enrolled
November 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedJuly 14, 2016
July 1, 2016
2.4 years
July 8, 2004
July 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hot flash reduction by diary record at 4 weeks
at 4 weeks
Secondary Outcomes (1)
Toxicity by questionnaires at 4 weeks
at 4 weeks
Study Arms (2)
gabapentin + antidepressant
EXPERIMENTALPatients continue to receive the same antidepressant (as before study entry) on weeks 1-5. During weeks 2-5, patients also receive oral gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity. Patients complete a hot flash diary at baseline and then daily during study treatment.
gabapentin
EXPERIMENTALPatients receive gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity. Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone. Patients complete a hot flash diary at baseline and then daily during study treatment.
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (162)
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, 85259, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224-9980, United States
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, 30912, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, 60507, United States
St. Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital
Canton, Illinois, 61520, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Galesburg Clinic
Galesburg, Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hopedale Medical Complex
Hopedale, Illinois, 61747, United States
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois, 60435, United States
Kewanee Hospital
Kewanee, Illinois, 61443, United States
McDonough District Hospital
Macomb, Illinois, 61455, United States
Trinity Medical Center - East
Moline, Illinois, 61265, United States
BroMenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa, Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois - Ottawa
Ottawa, Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61603, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61615, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois Valley Community Hospital
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
St. Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Valley Cancer Center
Spring Valley, Illinois, 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
St. Francis Hospital and Health Centers
Beech Grove, Indiana, 46107, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360, United States
McFarland Clinic, P.C.
Ames, Iowa, 50010, United States
Saint Anthony Regional Hospital
Carroll, Iowa, 51401, United States
St. Luke's Hospital
Cedar Rapids, Iowa, 52402, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, 52403, United States
Mercy Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503, United States
Mercy Capitol Hospital
Des Moines, Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, 50401, United States
Alegent Health Community Memorial Hospital
Missouri Valley, Iowa, 51555, United States
Burgess Health Center
Onawa, Iowa, 51040, United States
Cancer Center at Ottumwa Regional Health Center
Ottumwa, Iowa, 52501, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101-1733, United States
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, 50266, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Kingman
Kingman, Kansas, 67068, United States
Southwest Medical Center
Liberal, Kansas, 67901, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, 67357, United States
Pratt Cancer Center of Kansas
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67042, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health
Wichita, Kansas, 67203, United States
Cancer Center of Kansas, P.A.
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48100, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48532, United States
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, 49801, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48909, United States
Seton Cancer Institute - Saginaw
Saginaw, Michigan, 48601, United States
St. John Macomb Hospital
Warren, Michigan, 48903, United States
MeritCare Clinic - Bemidji
Bemidji, Minnesota, 56601, United States
Brainerd Medical Center
Brainerd, Minnesota, 56401, United States
St. Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Mercy and Unity Hospitals
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, 55355, United States
St. John's Hospital
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
Chippewa County - Montevideo Hospital
Montevideo, Minnesota, 56265, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Adult and Pediatric Urology, P.L.L.P.
Saint Cloud, Minnesota, 56303, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, 56303, United States
St. Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic
Saint Louis Park, Minnesota, 55416, United States
Cancer Care Center at Regions Hospital
Saint Paul, Minnesota, 55101, United States
St. Joseph's Hospital
Saint Paul, Minnesota, 55102, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Cancer Center
Shakopee, Minnesota, 55379, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Woodwinds Hospital
Woodbury, Minnesota, 55125, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
St. Vincent Healthcare
Billings, Montana, 59101, United States
Deaconess Billings Clinic Cancer Center
Billings, Montana, 59107, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
St. James Community Hospital
Butte, Montana, 59701, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Sletten Regional Cancer Institute
Great Falls, Montana, 59405, United States
St. Peter's Hospital
Helena, Montana, 59601, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Eastern Montana Cancer Center
Miles City, Montana, 59301, United States
Community Medical Center
Missoula, Montana, 59801, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59802, United States
Fremont Area Medical Center
Fremont, Nebraska, 68025, United States
Bryan LGH Medical Center West
Lincoln, Nebraska, 68502, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 68510, United States
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Cancer Center at Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, 68046, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
Bismarck Cancer Center
Bismarck, North Dakota, 58501, United States
Medcenter One Health System
Bismarck, North Dakota, 58501, United States
Mid Dakota Clinic, P.C.
Bismarck, North Dakota, 58501, United States
St. Alexius Medical Center
Bismarck, North Dakota, 58501, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122, United States
MeritCare Medical Group
Fargo, North Dakota, 58122, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital
Dayton, Ohio, 45406, United States
Samaritan North Cancer Care Center
Dayton, Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428, United States
CCOP - Dayton
Dayton, Ohio, 45429, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429, United States
Middletown Regional Hospital
Middletown, Ohio, 45044, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373, United States
United States Air Force Medical Center Wright-Patterson
Wright-Patterson AFB, Ohio, 45433-5529, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, 18105, United States
Guthrie Medical Center - Sayre
Sayre, Pennsylvania, 18840, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, 29621, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29304, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, 57104, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57105, United States
Medical X-Ray Center
Sioux Falls, South Dakota, 57105, United States
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
St. Vincent Hospital
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center
Green Bay, Wisconsin, 54303, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Related Publications (2)
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.
PMID: 17146104RESULTLoprinzi 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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Charles L. Loprinzi, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2004
First Posted
July 12, 2004
Study Start
November 1, 2004
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
July 14, 2016
Record last verified: 2016-07