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Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00049309
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Duke University

Tracking Information
First Submitted Date  ICMJE November 12, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date February 23, 2017
Study Start Date  ICMJE January 2003
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2007)
Prostatic Carcinoma Proliferation Rate by MIB-1 assay at time of prostatectomy
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2007)
  • Prostatic Carcinoma Apoptotic Index by TUNEL assay at time of prostatectomy
  • Prostate-specific antigen by Hybritech assay at baseline and follow-up
  • Total testosterone, sex hormone binding globulin, insulin-like growth factor (IGF), and IGF-binding protein-3, total cholesterol, and low-density lipoprotein cholesterol by ELISA assays at baseline and follow-up
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer
Official Title  ICMJE Prostate Cancer: Impact Of Fat And Flaxseed - Modified Diets
Brief Summary

RATIONALE: A diet that is low in fat and/or high in flaxseed may slow or prevent disease progression of prostate cancer.

PURPOSE: Randomized phase 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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Dietary Supplement: dietary intervention
  • Dietary Supplement: flaxseed
Study Arms  ICMJE
  • No Intervention: Control
    Usual diet
  • Experimental: Flaxseed diet
    30 gram flaxseed dietary modification
    Intervention: Dietary Supplement: flaxseed
  • Experimental: Low fat diet
    Low fat dietary modification
    Intervention: Dietary Supplement: dietary intervention
  • Experimental: Low fat + Flaxseed diet
    Low fat and 30 gram flaxseed dietary modification
    Interventions:
    • Dietary Supplement: dietary intervention
    • Dietary Supplement: flaxseed
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2013)
161
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2006
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 except standard multivitamin/mineral preparations (e.g., One-A-Day, Theragran, or Centrum) that do not supply > 100% of the recommended daily allowance of any vitamin or mineral
  • No other concurrent neoadjuvant therapies
  • No other concurrent flaxseed consumption
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00049309
Other Study ID Numbers  ICMJE Pro00008602
DUMC-1385-02-7R3ER
NCI-P02-0235
CCUM-0202
UMCC-0202
CDR0000258042 ( Other Identifier: NCI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Wendy Demark-Wahnefried, PhD Duke Cancer Institute
PRS Account Duke University
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP