Gabapentin With or Without Antidepressants in Treating Hot Flashes in Women Who Have Had Breast Cancer or Have Concerns About Taking Hormone Therapy
- Registration Number
- NCT00087399
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
- Detailed Description
OBJECTIVES:
* Compare the efficacy of gabapentin with vs without an antidepressant, as measured by the frequency and intensity of hot flashes, in patients with a history of breast cancer or a concern about taking hormonal therapy due to a fear of developing breast cancer.
* Compare adverse events in patients treated with these regimens.
* Correlate a reduction in hot flash scores with improvement in quality of life and related outcomes in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to duration of hot flash symptoms (\< 9 months vs ≥ 9 months), average frequency of hot flashes per day (2-3 vs 4-9 vs ≥ 10), and antidepressant currently being used (venlafaxine vs paroxetine vs other). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients 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.
* Arm II: Patients receive gabapentin as in arm I. Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone (per arm I schedule).
Patients in both arms complete a hot flash diary at baseline and then daily during study treatment.
Quality of life is assessed at baseline and then weekly during study treatment.
PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 118
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description gabapentin + antidepressant gabapentin Patients 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 + antidepressant antidepressant Patients 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 gabapentin Patients 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.
- Primary Outcome Measures
Name Time Method Hot flash reduction by diary record at 4 weeks at 4 weeks
- Secondary Outcome Measures
Name Time Method Toxicity by questionnaires at 4 weeks at 4 weeks
Trial Locations
- Locations (162)
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
Siouxland Regional Cancer Center
🇺🇸Sioux City, Iowa, United States
St. Cloud Hospital
🇺🇸Saint Cloud, Minnesota, United States
Guthrie Medical Center - Sayre
🇺🇸Sayre, Pennsylvania, United States
Eureka Hospital
🇺🇸Eureka, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Sletten Regional Cancer Institute
🇺🇸Great Falls, Montana, United States
Deaconess Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
Seton Cancer Institute - Saginaw
🇺🇸Saginaw, Michigan, United States
Green Bay Oncology, Limited - Escanaba
🇺🇸Escanaba, Michigan, United States
Deaconess Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
🇺🇸Anderson, South Carolina, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Eastern Montana Cancer Center
🇺🇸Miles City, Montana, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Bozeman Deaconess Hospital
🇺🇸Bozeman, Montana, United States
St. James Community Hospital
🇺🇸Butte, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Green Bay Oncology, Limited - Iron Mountain
🇺🇸Iron Mountain, Michigan, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Medcenter One Health System
🇺🇸Bismarck, North Dakota, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Fremont Area Medical Center
🇺🇸Fremont, Nebraska, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
🇺🇸Robbinsdale, Minnesota, United States
St. Joseph's Hospital
🇺🇸St Paul, Minnesota, United States
Adult and Pediatric Urology, P.L.L.P.
🇺🇸St. Cloud, Minnesota, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
MeritCare Medical Group
🇺🇸Fargo, North Dakota, United States
Cancer Center of Kansas - Winfield
🇺🇸Winfield, Kansas, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Brainerd Medical Center
🇺🇸Brainerd, Minnesota, United States
Meeker County Memorial Hospital
🇺🇸Litchfield, Minnesota, United States
Woodwinds Hospital
🇺🇸Woodbury, Minnesota, United States
CentraCare Clinic - River Campus
🇺🇸St. Cloud, Minnesota, United States
United Hospital
🇺🇸St. Paul, Minnesota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Saint Francis Cancer Center
🇺🇸Shakopee, Minnesota, United States
Welch Cancer Center
🇺🇸Sheridan, Wyoming, United States
Chippewa County - Montevideo Hospital
🇺🇸Montevideo, Minnesota, United States
Mid Dakota Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
Park Nicollet Clinic
🇺🇸St. Louis Park, Minnesota, United States
St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
Cancer Care Center at Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
MeritCare Clinic - Bemidji
🇺🇸Bemidji, Minnesota, United States
Mercy and Unity Cancer Center at Mercy and Unity Hospitals
🇺🇸Fridley, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
St. Joseph's Medical Center
🇺🇸Brainerd, Minnesota, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
InterCommunity Cancer Center of Western Illinois
🇺🇸Galesburg, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Joliet Oncology Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Trinity Medical Center - East
🇺🇸Moline, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois - Ottawa
🇺🇸Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Valley Cancer Center
🇺🇸Spring Valley, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
St. Francis Hospital and Health Centers
🇺🇸Beech Grove, Indiana, United States
McFarland Clinic, P.C.
🇺🇸Ames, Iowa, United States
Saint Anthony Regional Hospital
🇺🇸Carroll, Iowa, United States
St. Luke's Hospital
🇺🇸Cedar Rapids, Iowa, United States
Mercy Cancer Center at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Alegent Health Mercy Hospital
🇺🇸Council Bluffs, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
🇺🇸Mason City, Iowa, United States
Alegent Health Community Memorial Hospital
🇺🇸Missouri Valley, Iowa, United States
Cancer Center at Ottumwa Regional Health Center
🇺🇸Ottumwa, Iowa, United States
Siouxland Hematology-Oncology Associates
🇺🇸Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas - Chanute
🇺🇸Chanute, Kansas, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸West Des Moines, Iowa, United States
Cancer Center of Kansas - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, P.A. - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas - Kingman
🇺🇸Kingman, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons
🇺🇸Parsons, Kansas, United States
Pratt Cancer Center of Kansas
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, P.A.
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas - Wellington
🇺🇸Wellington, Kansas, United States
Associates in Womens Health
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Green Bay Oncology, Limited - Oconto Falls
🇺🇸Oconto Falls, Wisconsin, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Bryan LGH Medical Center West
🇺🇸Lincoln, Nebraska, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Avera McKennan Hospital and University Health Center
🇺🇸Sioux Falls, South Dakota, United States
St. Vincent Healthcare
🇺🇸Billings, Montana, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Midlands Cancer Center at Midlands Community Hospital
🇺🇸Papillion, Nebraska, United States
St. Elizabeth Regional Medical Center
🇺🇸Lincoln, Nebraska, United States
Green Bay Oncology, Limited at St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center
🇺🇸Green Bay, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
MBCCOP-Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
United States Air Force Medical Center Wright-Patterson
🇺🇸Wright-Patterson Afb, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Cancer Center at Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Medical X-Ray Center
🇺🇸Sioux Falls, South Dakota, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Burgess Health Center
🇺🇸Onawa, Iowa, United States