Clinical trial · Interventional
Low-Fat Diet and/or Flaxseed in Preventing Prostate Cancer
Prostate Cancer: Impact Of Fat And Flaxseed - Modified Diets
NCT00049309CI-TRIAL-00026107completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dietary intervention | Dietary Supplement | — | UNRESOLVED |
| flaxseed | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Control
- description
- Usual diet
- type
- EXPERIMENTAL
- label
- Flaxseed diet
- description
- 30 gram flaxseed dietary modification
- interventionNames
- Dietary Supplement: flaxseed
- type
- EXPERIMENTAL
- label
- Low fat diet
- description
- Low fat dietary modification
- interventionNames
- Dietary Supplement: dietary intervention
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDDemark-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
- BACKGROUNDLin 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
- RESULTDemark-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
- RESULTDemark-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
- RESULTHeymach 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
- RESULTAzrad 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.