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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014