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Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer Clinical research trials and Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer. Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer clinical trial. Participants oftentimes recieve the most expert healthcare available for their Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer  Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer
Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer
For Condition: stage 3 prostate cancer,stage 1 prostate cancer,stage 2 prostate cancer
Status: Recruiting
Sponsor(s): University of Michigan Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: A diet that is low in fat and/or high in flaxseed may slow or prevent disease progression of prostate cancer. PURPOSE: Randomizedphase II trial to study the effectiveness of a diet that is low in fat and/or high in flaxseed in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer.
Details: OBJECTIVES: - Compare tumor proliferation in patients with newly diagnosed prostate cancer eating fat- and/or flaxseed-modified diets. - Compare differences in histopathological markers associated with prostate cancer (rates of apoptosis, extent of high-grade prostatic intraepithelial neoplasia) among patients in these diet groups. - Compare changes in serum prostate specific antigen among patients in these diet groups. - Compare changes in hormone-related factors (total serum testosterone and free androgen index, insulin-like growth factor [IGF], and IGF-binding protein-3) among patients in these diet groups. - Compare the effects of diet on nutritional biomarkers (levels of lignans in the urine and ejaculate, fatty acid profiles of erythrocytes and prostatic tissue) in these patients. - Determine associations between dietary modification and changes in dietary biomarkers, hormonal intermediates, and study endpoints in these patients. OUTLINE: This is a randomized study. Patients are stratified according to Gleason score (less than 7 vs at least 7) and race (black vs non-black). Patients are randomized to 1 of 4 diet groups. - Arm I (Flaxseed-supplemented diet): Patients are instructed to incorporate ground flaxseed into their daily diets. - Arm II (Low-fat diet): Patients are instructed on ways to achieve a diet with no greater than 20% of total energy from dietary fat. - Arm III (Flaxseed-supplemented, low-fat diet): Patients are instructed as in arm I and arm II. - Arm IV (Control diet): Patients are contacted weekly, but do not receive dietary counseling until after surgery. All patients ingest the diets for at least 3 weeks and complete diet diaries until surgery. After surgery, all patients receive dietary counseling. PROJECTED ACCRUAL: A total of 160 patients (40 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed prostate cancer - At least 3 weeks until planned prostatectomy (24 days between day 1 visit and surgery) - Current diet that provides more than 30% of calories from fat PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Mentally competent - Able to speak and write English - Must have telephone access PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - No concurrent hormonal therapy Radiotherapy - Not specified Surgery - At least 2 weeks since prior prostate biopsy Other - At least 7 days since prior antibiotics - No prior therapy for prostate cancer - No concurrent dietary supplements initiated within the past 3 months or anticipated to begin during study - No other concurrent neoadjuvant therapies - No other concurrent flaxseed consumption
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DeanBrenner, Study Chair, University of Michigan Comprehensive Cancer Center
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Wendy Demark-Wahnefried 919-681-3261
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7295
United States
Recruiting Boyd Switzer 919-966-7221
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0930
United States
Recruiting Dean Brenner 734-647-1417
Additional Information:
Study ID Numbers: CDR0000258042; CCUM-0202,UMCC-0202,NCI-P02-0235,DUMC-1385-02-7R3ER
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049309
Other Stage 2 Prostate Cancer Studies:
1. Magnetic Resonance Imaging and Magnetic Resonance Spectroscopic Imaging in Diagnosing the Extent of Disease in Patients With Prostate Cancer
2. Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer
3. Low-Fat, High-Fiber Diet Compared to a Standard Diet in Treating Patients With Prostate Cancer
4. Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
5. Group Therapy Compared With Educational Materials in Patients With Prostate Cancer
Related Studies:
Other stage 2 prostate cancer Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer
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