|
Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer Clinical research trials and Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer. Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer clinical trial. Human subjects often get the best healthcare possible for their Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "G" Clinical Trials Conditions > Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer  Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
For Condition: recurrent prostate cancer,stage 3 prostate cancer,stage 4 prostate cancer,Hot Flashes,stage 2 prostate cancer,stage 1 prostate cancer
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase III trial to compare different regimens of gabapentin in treating men who have prostate cancer.
Details: 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. - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of prostate cancer - Received or are currently receiving androgen ablation therapy - Hot flashes for at least 1 month - At least 14 times per week and severe enough to require therapeutic intervention PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - At least 6 months Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Creatinine less than 1.5 times upper limit of normal over the past 2 years Other: - No prior allergic or adverse reaction to gabapentin PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 4 weeks since prior antineoplastic chemotherapy - No concurrent antineoplastic chemotherapy Endocrine therapy: - See Disease Characteristics - At least 4 weeks since prior androgens, estrogens, or progestational agents - No concurrent androgens, estrogens, or progestational agents - Concurrent hormonal therapy allowed if on stable dose for at least 4 weeks and plan to continue therapy throughout study Radiotherapy: - Not specified Surgery: - Not specified Other: - No prior gabapentin - No other concurrent treatment for hot flashes - Concurrent antidepressants allowed if on stable dose for at least 1 month and plan to continue therapy throughout study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesLoprinzi, Study Chair, Mayo Clinic Cancer Center
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-544-1013
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Daniel Nikcevich 218-786-3625
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Medcenter One Health System *Recruiting*
Bismark, North Dakota, 58501-5505
United States
Recruiting Edward Wos 701-323-5741
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting Mark Olsen 918-499-2000
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
CentraCare Health Plaza *Recruiting*
St. Cloud, Minnesota, 56303
United States
Recruiting Harold Windschitl 320-229-5199
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Charles Loprinzi 507-284-8964
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Additional Information:
Study ID Numbers: CDR0000069107; NCCTG-N00CB,NCI-P01-0199
Study Start Date:
Record last reviewed: February 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028574
Other Stage 4 Prostate Cancer Studies:
1. Radiation Therapy in Treating Patients With Prostate Cancer
2. Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
3. Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer
4. Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate
5. Brachytherapy in Treating Patients With Recurrent Prostate Cancer
Related Studies:
Other stage 4 prostate cancer Clinical Trials
Other Iowa Clinical Trials
Other Des Moines Clinical Trials
Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
|
|
|
|
|
|
|
|
