Low-Fat Diet + Fish Oil for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: Finasteride, Dutasteride, Fish oil

Disqualifiers: Prior prostate cancer treatment, Fish allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 year

107 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase II trial will evaluate if a low omega-6, high omega-3 fat diet combined with fish oil has the potential to delay disease progression in patients with prostate cancer undergoing active surveillance.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take lycopene, green tea, pomegranate supplements, or pomegranate juice during the study. If you are in the control group, you also cannot take fish oil capsules.

What data supports the effectiveness of the treatment involving a low-fat diet and fish oil for prostate cancer?

Research suggests that a low-fat diet combined with fish oil may help slow down prostate cancer progression by reducing cancer cell growth and improving the balance of fatty acids in the prostate. Specifically, omega-3 fatty acids like EPA found in fish oil are linked to a reduced risk of cancer progression. ^{1 2 3 4 5}

Is the combination of a low-fat diet and fish oil safe for humans?

The studies suggest that a low-fat diet combined with fish oil is generally safe for humans, as no significant adverse effects were reported in the trials. The intervention was associated with positive changes in prostate cancer markers, indicating it may be beneficial without harmful side effects. ^{1 2 6 7 8}

How does the low-fat diet with fish oil treatment differ from other prostate cancer treatments?

This treatment is unique because it combines a low-fat diet with fish oil, which is rich in omega-3 fatty acids. These components may help slow prostate cancer progression by reducing inflammation and altering the balance of fatty acids in the body, unlike traditional treatments that often focus on surgery, radiation, or hormone therapy. ^{1 3 5 9 10}

Research Team

William Aronson

Principal Investigator

Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for men with prostate cancer who are on active surveillance, have a Gleason grade of 3+4 or less, and a PSA level under 20. They must not consume certain supplements or fish oil capsules during the study and be able to visit UCLA for check-ups. Men who've had prior prostate cancer treatments or take specific medications can't join.

Inclusion Criteria

Patients sign the informed consent

I agree not to take fish oil capsules if placed in the control group.

PSA < 20

Exclusion Criteria

I have taken finasteride or dutasteride in the last year.

I have had treatment for prostate cancer before.

My prostate cancer was found in just one biopsy core and affects less than 5% of that sample.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dietary counseling and follow a low omega-6, high omega-3 fat diet combined with fish oil for 1 year

1 year

Weekly visits for 1 month, then monthly visits for 11 months

Follow-up

Participants are monitored for long-term clinical outcomes and safety

15 years

Yearly visits

Treatment Details

Interventions

• Behavioral Dietary Intervention
• Omega-3 Fatty Acid

Trial Overview The trial is testing if a low-fat diet combined with fish oil supplements can slow down prostate cancer progression in patients opting for active surveillance rather than immediate treatment.

Participant Groups

Group I: Arm II (fish oil) Experimental Treatment 3 Interventions

Patients receive dietary counseling with research dietitian weekly for 1 month and then monthly for 11 months. Patients are given guidelines with recommended meals to follow a low omega-6, high omega-3 fat diet combined with fish oil. Patients also receive 4 fish oil capsules per day PO for 1 year.

Group II: Arm I (control) Active Control 1 Intervention

Patients receive no intervention.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Pharmavite LLC

Industry Sponsor

Trials

12

Recruited

27,200+

Seafood Industry Research Fund

Collaborator

Trials

2

Recruited

210+

Findings from Research

An omega-3 (ω3) enriched diet significantly reduced prostate tumor growth in both immune-competent and castrated mice, suggesting its potential as a dietary intervention against prostate cancer.

The ω3 diet increased levels of cytokines associated with an anti-tumor immune response, indicating that it may enhance local inflammation that fights tumor growth, regardless of androgen levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids decrease prostate cancer progression associated with an anti-tumor immune response in eugonadal and castrated mice. Gevariya, N., Besançon, M., Robitaille, K., et al.[2019]

Men with prostate cancer can successfully adhere to a low-fat diet (15% fat or less) for 12 months when provided with proper nutritional counseling, as shown by significant reductions in fat intake and weight loss.

Participants receiving low-fat dietary counseling lost an average of 2.8 kg over 12 months, while those not receiving counseling gained weight, indicating the effectiveness of dietary guidance in managing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to a low-fat diet in men with prostate cancer. Link, LB., Thompson, SM., Bosland, MC., et al.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prostatic and dietary omega-3 fatty acids and prostate cancer progression during active surveillance. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Phase II prospective randomized trial of a low-fat diet with fish oil supplementation in men undergoing radical prostatectomy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids decrease prostate cancer progression associated with an anti-tumor immune response in eugonadal and castrated mice. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Bridging animal and human studies: what are the missing segments in dietary fat and prostate cancer? [2018]

5. India pubmed.ncbi.nlm.nih.gov

Systematic review of prostate cancer risk and association with consumption of fish and fish-oils: analysis of 495,321 participants. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Association of the Omega-3 Index with Incident Prostate Cancer with Updated Meta-Analysis: The Cooper Center Longitudinal Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Mechanisms of omega-3 polyunsaturated fatty acids in prostate cancer prevention. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Validation of the omega-3 fatty acid intake measured by a web-based food frequency questionnaire against omega-3 fatty acids in red blood cells in men with prostate cancer. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Modulation of omega-3/omega-6 polyunsaturated ratios with dietary fish oils in men with prostate cancer. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Adherence to a low-fat diet in men with prostate cancer. [2013]