Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
- Registration Number
- NCT00028574
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
- Detailed Description
OBJECTIVES:
* Determine the effectiveness of gabapentin in managing hot flashes in men with prostate cancer.
* Determine the response of patients to this drug.
* Determine the toxicity of this drug in these patients.
* Determine the quality of life of patients treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to the number of hot flashes per day (2-3 vs 4-9 vs 10 or more) and duration of hot flash symptoms (less than 9 months vs 9 months or more). Patients are randomized to one of four treatment arms.
All patients are observed for 7 days prior to drug administration in order to collect baseline hot flash information.
* Arm I: Patients receive oral gabapentin once daily on days 1-28.
* Arm II: Patients receive oral gabapentin once daily on days 1-7 and twice daily on days 8-28.
* Arm III: Patients receive oral gabapentin once daily on days 1-7, twice daily on days 8-14, and three times daily on days 15-28.
* Arm IV: Patients receive oral placebo on one of three schedules corresponding to arms I-III.
Patients in all arms may continue therapy with gabapentin for an additional 8 weeks.
Quality of life is assessed at baseline, day 28, and at the end of the additional 8 weeks.
Patients are followed at 6, 12, and 24 months.
PROJECTED ACCRUAL: A total of 220 patients (55 per treatment arm) will be accrued for this study within 1 year.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 223
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gabapentin (7, 21) gabapentin Oral Gabapentin 300 mg once daily on days 1-7 days and twice daily days 8-28 Placebo placebo Oral Placebo 300 mg on one of the following schedules: * once daily on days 1-28 * once daily on days 1-7, twice daily on days 8-28 * once daily on days 1-7, twice daily on days 8-14 and three times daily on days 15-28 Gabapentin (28 days) gabapentin Oral Gabapentin 300 mg days 1-28 Gabapentin (7, 7, 14) gabapentin Oral Gabapentin 300 mg once daily on days 1-7, twice daily on days 8-14 and three times daily on days 15-28
- Primary Outcome Measures
Name Time Method Hot flash reduction by diary scores at 4 weeks 5 weeks from study entry
- Secondary Outcome Measures
Name Time Method Toxicity by questionnaires at 4 weeks 5 weeks from study entry
Trial Locations
- Locations (165)
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
Siouxland Regional Cancer Center
🇺🇸Sioux City, Iowa, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
St. Mary's - Duluth Clinic Cancer Center
🇺🇸Duluth, Minnesota, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
🇺🇸Lambertville, Michigan, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Kalispell Medical Oncology
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
Cancer Care Center at Medcenter One Hospital
🇺🇸Bismarck, North Dakota, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Grant Riverside Cancer Services
🇺🇸Columbus, Ohio, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Kenton Oncology, Incorporated
🇺🇸Kenton, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
AnMed Health Cancer Center
🇺🇸Anderson, South Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
St. James Community Hospital
🇺🇸Butte, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Bozeman Deaconess Hospital
🇺🇸Bozeman, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸West Des Moines, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Ottumwa Regional Health Center Cancer Center
🇺🇸Ottumwa, Iowa, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Albert Lea Cancer Center at Albert Lea Medical Center
🇺🇸Albert Lea, Minnesota, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Coborn Cancer Center
🇺🇸Saint Cloud, Minnesota, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Foote Hospital
🇺🇸Jackson, Michigan, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
St. Vincent Healthcare
🇺🇸Billings, Montana, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Mercy Memorial Hospital System
🇺🇸Monroe, Michigan, United States
Chippewa County - Montevideo Hospital
🇺🇸Montevideo, Minnesota, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
St. Joseph's Medical Center
🇺🇸Brainerd, Minnesota, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Clinic of Dr. Judy L. Schmidt
🇺🇸Missoula, Montana, United States
Mid Dakota Clinic, P. C.
🇺🇸Bismarck, North Dakota, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
Fremont Memorial Hospital
🇺🇸Fremont, Ohio, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
Mercy Medical Center
🇺🇸Springfield, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Firelands Regional Medical Center
🇺🇸Sandusky, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Miller-Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
Brainerd Medical Center
🇺🇸Brainerd, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
CentraCare Clinic - River Campus
🇺🇸St. Cloud, Minnesota, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Seton Cancer Institute - Saginaw
🇺🇸Saginaw, Michigan, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Howard University Cancer Center at Howard University Hospital
🇺🇸Washington, District of Columbia, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Kapiolani Medical Center at Pali Momi
🇺🇸Aiea, Hawaii, United States
Cancer Research Center of Hawaii
🇺🇸Honolula, Hawaii, United States
Leeward Radiation Oncology Center
🇺🇸Ewa Beach, Hawaii, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
St. Anthony's Memorial Hospital
🇺🇸Effingham, Illinois, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Trinity Medical Center - East
🇺🇸Moline, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
🇺🇸Mason City, Iowa, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Adult and Pediatric Urology, P.L.L.P.
🇺🇸Sartell, Minnesota, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
🇺🇸Westerville, Ohio, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Allegheny Cancer Center at Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
OnCare Hawaii, Incorporated - Lusitana
🇺🇸Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated
🇺🇸Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini
🇺🇸Honolulu, Hawaii, United States
St. Francis Medical Center
🇺🇸Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, 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
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸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
Alegant Health Cancer Center at Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Deaconess Billings Clinic - Downtown
🇺🇸Billings, Montana, United States