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| Sponsor: | North Central Cancer Treatment Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028574 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hot Flashes Prostate Cancer |
Drug: gabapentin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men |
| Estimated Enrollment: | 220 |
| Study Start Date: | December 2001 |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hot flashes for at least 1 month
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Mobile Infirmary Medical Center | |
| Mobile, Alabama, United States, 36652-2144 | |
| United States, District of Columbia | |
| Howard University Cancer Center at Howard University Hospital | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolula, Hawaii, United States, 96813 | |
| Kapiolani Medical Center at Pali Momi | |
| Aiea, Hawaii, United States, 96701 | |
| Kapiolani Medical Center for Women and Children | |
| Honolulu, Hawaii, United States, 96826 | |
| Straub Clinic and Hospital, Incorporated | |
| Honolulu, Hawaii, United States, 96813 | |
| OnCare Hawaii, Incorporated - Kuakini | |
| Honolulu, Hawaii, United States, 96817 | |
| OnCare Hawaii, Incorporated - Lusitana | |
| Honolulu, Hawaii, United States, 96813 | |
| Queen's Cancer Institute at Queen's Medical Center | |
| Honolulu, Hawaii, United States, 96813 | |
| St. Francis Medical Center | |
| Honolulu, Hawaii, United States, 96817 | |
| Leeward Radiation Oncology Center | |
| Ewa Beach, Hawaii, United States, 96706 | |
| United States, Illinois | |
| BroMenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Cancer Treatment Center at Pekin Hospital | |
| Pekin, Illinois, United States, 61554 | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615 | |
| Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| Community Hospital of Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Moline, Illinois, United States, 61265 | |
| Eureka Community Hospital | |
| Eureka, Illinois, United States, 61530 | |
| Trinity Medical Center - East | |
| Moline, Illinois, United States, 61265 | |
| Galesburg Cottage Hospital | |
| Galesburg, Illinois, United States, 61401 | |
| Graham Hospital | |
| Canton, Illinois, United States, 61520 | |
| Hopedale Medical Complex | |
| Hopedale, Illinois, United States, 61747 | |
| Illinois Valley Community Hospital | |
| Peru, Illinois, United States, 61354 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| Kewanee Hospital | |
| Kewanee, Illinois, United States, 61443 | |
| Mason District Hospital | |
| Havana, Illinois, United States, 62644 | |
| McDonough District Hospital | |
| Macomb, Illinois, United States, 61455 | |
| Memorial Hospital | |
| Carthage, Illinois, United States, 62321 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | |
| Peoria, Illinois, United States, 61615 | |
| OSF St. Francis Medical Center | |
| Peoria, Illinois, United States, 61637 | |
| Perry Memorial Hospital | |
| Princeton, Illinois, United States, 61356 | |
| Proctor Hospital | |
| Peoria, Illinois, United States, 61614 | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60507 | |
| St. Anthony's Memorial Hospital | |
| Effingham, Illinois, United States, 62401 | |
| St. Joseph Medical Center | |
| Bloomington, Illinois, United States, 61701 | |
| St. Margaret's Hospital | |
| Spring Valley, Illinois, United States, 61362 | |
| Galesburg Clinic | |
| Galesburg, Illinois, United States, 61401 | |
| United States, Indiana | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| United States, Iowa | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309 | |
| Cedar Rapids Oncology Associates | |
| Cedar Rapids, Iowa, United States, 52403 | |
| Bettendorf, Iowa, United States, 52722 | |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | |
| Des Moines, Iowa, United States, 50316-2301 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| Medical Oncology and Hematology Associates - West Des Moines | |
| West Des Moines, Iowa, United States, 50266 | |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | |
| Des Moines, Iowa, United States, 50309 | |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | |
| Des Moines, Iowa, United States, 50314 | |
| McFarland Clinic, PC | |
| Ames, Iowa, United States, 50010 | |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | |
| Mason City, Iowa, United States, 50401 | |
| Mercy Capitol Hospital | |
| Des Moines, Iowa, United States, 50307 | |
| Mercy Medical Center - Sioux City | |
| Sioux City, Iowa, United States, 51104 | |
| Mercy Regional Cancer Center at Mercy Medical Center | |
| Cedar Rapids, Iowa, United States, 52403 | |
| Ottumwa Regional Health Center Cancer Center | |
| Ottumwa, Iowa, United States, 52501 | |
| Siouxland Hematology-Oncology Associates, LLP | |
| Sioux City, Iowa, United States, 51101 | |
| Siouxland Regional Cancer Center | |
| Sioux City, Iowa, United States, 51101 | |
| St. Luke's Hospital | |
| Cedar Rapids, Iowa, United States, 52402 | |
| St. Luke's Regional Medical Center | |
| Sioux City, Iowa, United States, 51104 | |
| United States, Kansas | |
| Associates in Womens Health, PA - North Review | |
| Wichita, Kansas, United States, 67203 | |
| Cancer Center of Kansas, PA - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Cancer Center of Kansas, PA - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, PA - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| Cancer Center of Kansas, PA - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| Cancer Center of Kansas, PA - El Dorado | |
| El Dorado, Kansas, United States, 67042 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | |
| Wichita, Kansas, United States, 67208 | |
| Cancer Center of Kansas, PA - Newton | |
| Newton, Kansas, United States, 67114 | |
| Cancer Center of Kansas, PA - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| Cancer Center of Kansas, PA - Pratt | |
| Pratt, Kansas, United States, 67124 | |
| Cancer Center of Kansas, PA - Salina | |
| Salina, Kansas, United States, 67042 | |
| Cancer Center of Kansas, PA - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Cancer Center of Kansas, PA - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Southwest Medical Center | |
| Liberal, Kansas, United States, 67901 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Michigan | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Community Cancer Center of Monroe | |
| Monroe, Michigan, United States, 48162 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Genesys Hurley Cancer Institute | |
| Flint, Michigan, United States, 48503 | |
| Haematology-Oncology Associates of Ohio and Michigan, PC | |
| Lambertville, Michigan, United States, 48144 | |
| Hickman Cancer Center at Bixby Medical Center | |
| Adrian, Michigan, United States, 49221 | |
| Foote Hospital | |
| Jackson, Michigan, United States, 49201 | |
| Mercy Memorial Hospital System | |
| Monroe, Michigan, United States, 48162 | |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | |
| Dearborn, Michigan, United States, 48123-2500 | |
| Seton Cancer Institute - Saginaw | |
| Saginaw, Michigan, United States, 48601 | |
| Sparrow Regional Cancer Center | |
| Lansing, Michigan, United States, 48909 | |
| St. John Macomb Hospital | |
| Warren, Michigan, United States, 48093 | |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| United States, Minnesota | |
| Adult and Pediatric Urology, P.L.L.P. | |
| Sartell, Minnesota, United States, 56377 | |
| Albert Lea Cancer Center at Albert Lea Medical Center | |
| Albert Lea, Minnesota, United States, 56007 | |
| Brainerd Medical Center | |
| Brainerd, Minnesota, United States, 56401 | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| CentraCare Clinic - River Campus | |
| St. Cloud, Minnesota, United States, 56303 | |
| Chippewa County - Montevideo Hospital | |
| Montevideo, Minnesota, United States, 56265 | |
| Coborn Cancer Center | |
| Saint Cloud, Minnesota, United States, 56303 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Miller-Dwan Medical Center | |
| Duluth, Minnesota, United States, 55805 | |
| St. Joseph's Medical Center | |
| Brainerd, Minnesota, United States, 56401 | |
| St. Mary's - Duluth Clinic Cancer Center | |
| Duluth, Minnesota, United States, 55805 | |
| Willmar Cancer Center at Rice Memorial Hospital | |
| Willmar, Minnesota, United States, 56201 | |
| Fergus Falls, Minnesota, United States, 56537 | |
| Alexandria, Minnesota, United States, 56308 | |
| United States, Montana | |
| Bozeman Deaconess Hospital | |
| Bozeman, Montana, United States, 59715 | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Clinic of Dr. Judy L. Schmidt | |
| Missoula, Montana, United States, 59804 | |
| Community Medical Center | |
| Missoula, Montana, United States, 59801 | |
| Deaconess Billings Clinic - Downtown | |
| Billings, Montana, United States, 59107-7000 | |
| Glacier Oncology, PLLC | |
| Kalispell, Montana, United States, 59901 | |
| Great Falls Clinic | |
| Great Falls, Montana, United States, 59405 | |
| Montana Cancer Specialists at Montana Cancer Center | |
| Missoula, Montana, United States, 59807-7877 | |
| Kalispell Medical Oncology | |
| Kalispell, Montana, United States, 59901 | |
| Kalispell Regional Medical Center | |
| Kalispell, Montana, United States, 59901 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
| Missoula, Montana, United States, 59807 | |
| Hematology-Oncology Centers of the Northern Rockies - Billings | |
| Billings, Montana, United States, 59101 | |
| Northern Rockies Radiation Oncology Center | |
| Billings, Montana, United States, 59101 | |
| St. James Community Hospital | |
| Butte, Montana, United States, 59701 | |
| St. Peter's Hospital | |
| Helena, Montana, United States, 59601 | |
| St. Vincent Healthcare | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | |
| Omaha, Nebraska, United States, 68124 | |
| Cancer Resource Center - Lincoln | |
| Lincoln, Nebraska, United States, 68510 | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68106 | |
| Creighton University Medical Center | |
| Omaha, Nebraska, United States, 68131-2197 | |
| Immanuel Medical Center | |
| Omaha, Nebraska, United States, 68122 | |
| United States, North Carolina | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139 | |
| United States, North Dakota | |
| Bismarck Cancer Center | |
| Bismarck, North Dakota, United States, 58501 | |
| Cancer Care Center at Medcenter One Hospital | |
| Bismarck, North Dakota, United States, 58501 | |
| Mid Dakota Clinic, P. C. | |
| Bismarck, North Dakota, United States, 58501 | |
| St. Alexius Medical Center | |
| Bismarck, North Dakota, United States, 58502 | |
| United States, Ohio | |
| Blanchard Valley Medical Associates | |
| Findlay, Ohio, United States, 45840 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43215 | |
| CCOP - Toledo Community Hospital | |
| Toledo, Ohio, United States, 43617 | |
| Community Hospital of Springfield and Clark County | |
| Springfield, Ohio, United States, 45505 | |
| Doctors Hospital at Ohio Health | |
| Columbus, Ohio, United States, 43228 | |
| Fairfield Medical Center | |
| Lancaster, Ohio, United States, 43130 | |
| Firelands Regional Medical Center | |
| Sandusky, Ohio, United States, 44870 | |
| Medical University of Ohio Cancer Center | |
| Toledo, Ohio, United States, 43614 | |
| Fremont Memorial Hospital | |
| Fremont, Ohio, United States, 43420 | |
| Fulton County Health Center | |
| Wauseon, Ohio, United States, 43567 | |
| Genesis - Good Samaritan Hospital | |
| Zanesville, Ohio, United States, 43701 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| Grant Riverside Cancer Services | |
| Columbus, Ohio, United States, 43215 | |
| Kenton Oncology, Incorporated | |
| Kenton, Ohio, United States, 43326 | |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | |
| Newark, Ohio, United States, 43055 | |
| Lima Memorial Hospital | |
| Lima, Ohio, United States, 45804 | |
| Flower Hospital Cancer Center | |
| Sylvania, Ohio, United States, 43560 | |
| Mercy Hospital of Tiffin | |
| Tiffin, Ohio, United States, 44883 | |
| Mercy Medical Center | |
| Springfield, Ohio, United States, 45504 | |
| Mount Carmel Health - West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | |
| Westerville, Ohio, United States, 43081 | |
| North Coast Cancer Care, Incorporated | |
| Sandusky, Ohio, United States, 44870 | |
| Northwest Ohio Oncology Center | |
| Maumee, Ohio, United States, 43537 | |
| Strecker Cancer Center at Marietta Memorial Hospital | |
| Marietta, Ohio, United States, 45750 | |
| St. Charles Mercy Hospital | |
| Oregon, Ohio, United States, 43616 | |
| St. Luke's Hospital | |
| Maumee, Ohio, United States, 43537 | |
| St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214-3998 | |
| Toledo Clinic - Oregon | |
| Oregon, Ohio, United States, 43616 | |
| Toledo Clinic, Incorporated - Main Clinic | |
| Toledo, Ohio, United States, 43623 | |
| Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| Wood County Oncology Center | |
| Bowling Green, Ohio, United States, 43402 | |
| United States, Pennsylvania | |
| Allegheny Cancer Center at Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, South Carolina | |
| AnMed Health Cancer Center | |
| Anderson, South Carolina, United States, 29621 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, South Dakota | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Wyoming | |
| Welch Cancer Center at Sheridan Memorial Hospital | |
| Sheridan, Wyoming, United States, 82801 | |
| Study Chair: | Charles L. Loprinzi, MD | Mayo Clinic |
| Investigator: | Debra Barton, RN, PhD, AOCN, FAAN | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000069107, NCCTG-N00CB, NCI-P01-0199 |
| Study First Received: | January 4, 2002 |
| Last Updated: | November 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00028574 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I prostate cancer stage II prostate cancer stage III prostate cancer |
stage IV prostate cancer recurrent prostate cancer hot flashes |
|
Neurotransmitter Agents Prostatic Diseases Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Hot Flashes Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Urogenital Neoplasms Membrane Transport Modulators Signs and Symptoms |
Neoplasms by Site Sensory System Agents Therapeutic Uses Analgesics Excitatory Amino Acid Antagonists Tranquilizing Agents Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Genital Diseases, Male Pharmacologic Actions Neoplasms Anti-Anxiety Agents Peripheral Nervous System Agents Prostatic Neoplasms |
