Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
NCT ID: NCT00028574
Last Updated: 2016-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
223 participants
INTERVENTIONAL
2001-12-31
2007-04-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare different regimens of gabapentin in treating men who have prostate cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Gabapentin (28 days)
Oral Gabapentin 300 mg days 1-28
gabapentin
Gabapentin (7, 21)
Oral Gabapentin 300 mg once daily on days 1-7 days and twice daily days 8-28
gabapentin
Gabapentin (7, 7, 14)
Oral Gabapentin 300 mg once daily on days 1-7, twice daily on days 8-14 and three times daily on days 15-28
gabapentin
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
placebo
Interventions
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gabapentin
placebo
Eligibility Criteria
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Inclusion Criteria
1. Men with a history of prostate cancer who have received or are receiving androgen ablation therapy.
2. Must be on a stable dose of hormone therapy for the past 4 weeks and must not be planning on discontinuing hormone therapy throughout the duration of the randomized phase (5 weeks).
3. Presence of hot flashes for ≥1 month prior to study entry.
4. Bothersome hot flashes (defined by their occurrence ≥14 times per week and of sufficient severity to make the patient desire therapeutic intervention).
5. Life expectancy ≥ 6 months.
6. ECOG Performance Status (PS) 0 or 1.
7. ≥18 years of age
Contraindications:
1. History of renal insufficiency (defined as a creatinine ≥1.5 x UNL in the last two years).
2. Any of the following current (≤ 4 weeks) or planned therapies:
* Antineoplastic chemotherapy
* Androgens
* Estrogens
* Progestational agents
3. History of allergic or other adverse reaction to gabapentin.
4. Prior use of gabapentin.
5. Antidepressants (use is allowed if patient has been on a stable dose for ≥1 month and does not plan to modify this treatment during the next 5 weeks).
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Charles Loprinzi, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Mobile Infirmary Medical Center
Mobile, Alabama, United States
Howard University Cancer Center at Howard University Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Cancer Research Center of Hawaii
Honolula, Hawaii, 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
Kapiolani Medical Center at Pali Momi
‘Aiea, Hawaii, United States
Leeward Radiation Oncology Center
‘Ewa Beach, Hawaii, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
St. Anthony's Memorial Hospital
Effingham, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Galesburg Clinic
Galesburg, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
Mason District Hospital
Havana, 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
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, PC - Ottawa
Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Illinois Valley Community Hospital
Peru, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
St. Margaret's Hospital
Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
McFarland Clinic, PC
Ames, Iowa, United States
Bettendorf, Iowa, United States
St. Luke's Hospital
Cedar Rapids, Iowa, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, 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
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States
Ottumwa Regional Health Center Cancer Center
Ottumwa, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Siouxland Regional Cancer Center
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
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, PA - 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
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 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
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Foote Hospital
Jackson, Michigan, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States
Sparrow Regional Cancer Center
Lansing, Michigan, United States
Community Cancer Center of Monroe
Monroe, Michigan, United States
Mercy Memorial Hospital System
Monroe, Michigan, United States
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States
St. John Macomb Hospital
Warren, Michigan, United States
Albert Lea Cancer Center at Albert Lea Medical Center
Albert Lea, Minnesota, United States
Alexandria, Minnesota, United States
Brainerd Medical Center
Brainerd, Minnesota, United States
St. Joseph's Medical Center
Brainerd, Minnesota, United States
CCOP - Duluth
Duluth, Minnesota, United States
Miller-Dwan Medical Center
Duluth, Minnesota, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States
Fergus Falls, Minnesota, United States
Chippewa County - Montevideo Hospital
Montevideo, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States
Coborn Cancer Center
Saint Cloud, Minnesota, United States
Adult and Pediatric Urology, P.L.L.P.
Sartell, Minnesota, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
St. Vincent Healthcare
Billings, Montana, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
St. James Community Hospital
Butte, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
Clinic of Dr. Judy L. Schmidt
Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 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
Rutherford Hospital
Rutherfordton, North Carolina, United States
Bismarck Cancer Center
Bismarck, North Dakota, United States
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota, United States
Mid Dakota Clinic, P. C.
Bismarck, North Dakota, United States
St. Alexius Medical Center
Bismarck, North Dakota, United States
Wood County Oncology Center
Bowling Green, Ohio, 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
Grady Memorial Hospital
Delaware, Ohio, United States
Blanchard Valley Medical Associates
Findlay, Ohio, United States
Fremont Memorial Hospital
Fremont, Ohio, United States
Kenton Oncology, Incorporated
Kenton, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Northwest Ohio Oncology Center
Maumee, Ohio, United States
St. Luke's Hospital
Maumee, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
St. Charles Mercy Hospital
Oregon, Ohio, United States
Toledo Clinic - Oregon
Oregon, Ohio, United States
Firelands Regional Medical Center
Sandusky, Ohio, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States
Mercy Medical Center
Springfield, Ohio, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States
Flower Hospital Cancer Center
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
Westerville, Ohio, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States
Countries
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References
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Loprinzi CL, Dueck AC, Khoyratty BS, Barton DL, Jafar S, Rowland KM Jr, Atherton PJ, Marsa GW, Knutson WH, Bearden JD 3rd, Kottschade L, Fitch TR. A phase III randomized, double-blind, placebo-controlled trial of gabapentin in the management of hot flashes in men (N00CB). Ann Oncol. 2009 Mar;20(3):542-9. doi: 10.1093/annonc/mdn644. Epub 2009 Jan 6.
Moraska AR, Atherton PJ, Szydlo DW, Barton DL, Stella PJ, Rowland KM Jr, Schaefer PL, Krook J, Bearden JD, Loprinzi CL. Gabapentin for the management of hot flashes in prostate cancer survivors: a longitudinal continuation Study-NCCTG Trial N00CB. J Support Oncol. 2010 May-Jun;8(3):128-32.
Other Identifiers
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NCCTG-N00CB
Identifier Type: -
Identifier Source: secondary_id
NCI-P01-0199
Identifier Type: -
Identifier Source: secondary_id
CDR0000069107
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02435
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-N00CB
Identifier Type: -
Identifier Source: org_study_id
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