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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00049309
First received: November 12, 2002
Last updated: April 9, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Dietary Supplement: dietary intervention
Dietary Supplement: flaxseed
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prostate Cancer: Impact Of Fat And Flaxseed - Modified Diets

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Prostatic Carcinoma Proliferation Rate by MIB-1 assay at time of prostatectomy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prostatic Carcinoma Apoptotic Index by TUNEL assay at time of prostatectomy [ Designated as safety issue: No ]
  • Prostate-specific antigen by Hybritech assay at baseline and follow-up [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Enrollment: 161
Study Start Date: January 2003
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Usual diet
Experimental: Flaxseed diet
30 gram flaxseed dietary modification
Dietary Supplement: flaxseed
Experimental: Low fat diet
Low fat dietary modification
Dietary Supplement: dietary intervention
Experimental: Low fat + Flaxseed diet
Low fat and 30 gram flaxseed dietary modification
Dietary Supplement: dietary intervention Dietary Supplement: flaxseed

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049309

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Wendy Demark-Wahnefried, PhD Duke Cancer Institute
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00049309     History of Changes
Other Study ID Numbers: Pro00008602, DUMC-1385-02-7R3ER, NCI-P02-0235, CCUM-0202, UMCC-0202, CDR0000258042
Study First Received: November 12, 2002
Last Updated: April 9, 2013
Health Authority: United States: Federal Government

Keywords provided by Duke University:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014