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

NCT00049309 | Completed Phase 2 DMC

• 6 other identifiers: Pro00008602DUMC-1385-02-7R3ERNCI-P02-0235CCUM-0202UMCC-0202CDR0000258042
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (1)

• Prostatic Carcinoma Proliferation Rate by MIB-1 assay at time of prostatectomy

Secondary Outcomes (3)

• 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

Study Arms (4)

Control

NO INTERVENTION

Usual diet

Flaxseed diet

EXPERIMENTAL

30 gram flaxseed dietary modification

Dietary Supplement: flaxseed

Low fat diet

EXPERIMENTAL

Low fat dietary modification

Dietary Supplement: dietary intervention

Low fat + Flaxseed diet

EXPERIMENTAL

Low fat and 30 gram flaxseed dietary modification

Dietary Supplement: dietary intervention; Dietary Supplement: flaxseed

Interventions

dietary intervention DIETARY_SUPPLEMENT

Low fat + Flaxseed diet; Low fat diet

flaxseed DIETARY_SUPPLEMENT

Flaxseed diet; Low fat + Flaxseed diet

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Related Publications (8)

• Demark-Wahnefried W, Robertson CN, Walther PJ, Polascik TJ, Paulson DF, Vollmer RT. Pilot study to explore effects of low-fat, flaxseed-supplemented diet on proliferation of benign prostatic epithelium and prostate-specific antigen. Urology. 2004 May;63(5):900-4. doi: 10.1016/j.urology.2003.12.010.

  PMID: 15134976 BACKGROUND

• Lin X, Gingrich JR, Bao W, Li J, Haroon ZA, Demark-Wahnefried W. Effect of flaxseed supplementation on prostatic carcinoma in transgenic mice. Urology. 2002 Nov;60(5):919-24. doi: 10.1016/s0090-4295(02)01863-0.

  PMID: 12429338 BACKGROUND

• Demark-Wahnefried W, Polascik TJ, George SL, Switzer BR, Madden JF, Ruffin MT 4th, Snyder DC, Owzar K, Hars V, Albala DM, Walther PJ, Robertson CN, Moul JW, Dunn BK, Brenner D, Minasian L, Stella P, Vollmer RT. Flaxseed supplementation (not dietary fat restriction) reduces prostate cancer proliferation rates in men presurgery. Cancer Epidemiol Biomarkers Prev. 2008 Dec;17(12):3577-87. doi: 10.1158/1055-9965.EPI-08-0008.

  PMID: 19064574 RESULT

• Demark-Wahnefried W, George SL, Switzer BR, Snyder DC, Madden JF, Polascik TJ, Ruffin MT 4th, Vollmer RT. Overcoming challenges in designing and implementing a phase II randomized controlled trial using a presurgical model to test a dietary intervention in prostate cancer. Clin Trials. 2008;5(3):262-72. doi: 10.1177/1740774508091676.

  PMID: 18559416 RESULT

• Heymach JV, Shackleford TJ, Tran HT, Yoo SY, Do KA, Wergin M, Saintigny P, Vollmer RT, Polascik TJ, Snyder DC, Ruffin MT 4th, Yan S, Dewhirst M, Kunnumakkara AB, Aggarwal BB, Demark-Wahnefried W. Effect of low-fat diets on plasma levels of NF-kappaB-regulated inflammatory cytokines and angiogenic factors in men with prostate cancer. Cancer Prev Res (Phila). 2011 Oct;4(10):1590-8. doi: 10.1158/1940-6207.CAPR-10-0136. Epub 2011 Jul 15.

  PMID: 21764858 RESULT

• Azrad M, Zhang K, Vollmer RT, Madden J, Polascik TJ, Snyder DC, Ruffin MT, Moul JW, Brenner D, Hardy RW, Demark-Wahnefried W. Prostatic alpha-linolenic acid (ALA) is positively associated with aggressive prostate cancer: a relationship which may depend on genetic variation in ALA metabolism. PLoS One. 2012;7(12):e53104. doi: 10.1371/journal.pone.0053104. Epub 2012 Dec 28.

  PMID: 23285256 RESULT

• Azrad M, Vollmer RT, Madden J, Dewhirst M, Polascik TJ, Snyder DC, Ruffin MT, Moul JW, Brenner DE, Demark-Wahnefried W. Flaxseed-derived enterolactone is inversely associated with tumor cell proliferation in men with localized prostate cancer. J Med Food. 2013 Apr;16(4):357-60. doi: 10.1089/jmf.2012.0159.

  PMID: 23566060 RESULT

• Azrad M, Vollmer RT, Madden J, Polascik TJ, Snyder DC, Ruffin MT 4th, Moul JW, Brenner D, He X, Demark-Wahnefried W. Disparate results between proliferation rates of surgically excised prostate tumors and an in vitro bioassay using sera from a positive randomized controlled trial. Biotech Histochem. 2015 Apr;90(3):184-9. doi: 10.3109/10520295.2014.976840. Epub 2014 Dec 1.

  PMID: 25434394 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diet Therapy; Linseed Oil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Wendy Demark-Wahnefried, PhD

  Duke Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2003
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: February 23, 2017

Record last verified: 2013-02

Locations

US (3)