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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a diet low in omega-6 fats and high in omega-3 fats, combined with fish oil, can slow prostate cancer in men opting for active surveillance instead of immediate treatment. Participants in one group will follow this special diet and take fish oil pills (omega-3 fatty acid), while another group will not change their treatment. The study seeks men diagnosed with prostate cancer who have not had recent treatments and can attend appointments at UCLA. As an unphased trial, it offers participants the chance to contribute to important research that could lead to new dietary recommendations for managing prostate cancer.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that omega-3 fatty acids, commonly found in fish oil, are generally safe for consumption. Studies have found that a diet high in omega-3 fats and low in omega-6 fats, combined with fish oil supplements, can help reduce signs linked to prostate cancer progression. This suggests the diet might not only be safe but also beneficial for prostate health.

While some studies have raised concerns about omega-3s, most research supports their safety. No strong evidence indicates that omega-3 fatty acids increase prostate cancer risk. Overall, fish oil and a diet high in omega-3s are well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of a low-fat diet rich in omega-3 fatty acids and fish oil for prostate cancer because it offers a non-invasive, dietary-based approach to managing the condition. Unlike traditional treatments such as surgery, radiation, or hormone therapy, this method focuses on modifying dietary habits to potentially slow cancer progression. The use of omega-3 fatty acids, known for their anti-inflammatory properties, is a key feature, as it could help reduce inflammation associated with cancer growth. This approach not only aims to support prostate health but also enhances overall well-being by integrating simple lifestyle changes.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that a diet low in omega-6 and high in omega-3, along with fish oil supplementation, might slow prostate cancer progression. In this trial, participants in Arm II will receive dietary counseling to follow this specific diet. Studies have found a link between higher omega-3 intake and a lower risk of developing prostate cancer. One study showed that this diet and fish oil combination significantly reduced prostate cancer cell growth. Another study observed a decrease in the cancer cell marker Ki67, indicating less cancer activity, in individuals following this diet. Omega-3s might also lower certain hormones in the tumor that promote cancer growth. These findings suggest that this diet could benefit prostate cancer patients under close monitoring. ^{4 6 7 8 9}

Who Is on the Research Team?

William Aronson

Principal Investigator

Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12318741/

Dietary Omega-3 intake may slow prostate cancer ... However, in the RCS analysis, we found that the greater the level of Omega-3 fatty acid intake was, the lower the risk of prostate cancer.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3232341/

Phase II Prospective Randomized Trial of a Low-Fat Diet ... Preclinical studies suggest lowering dietary fat and decreasing the ratio of omega-6 to omega-3 polyunsaturated fatty acids decreases the risk of prostate ...

3. ascopubs.org ascopubs.org/do/high-omega-3-low-omega-6-diet-fish-oil-and-prostate-cancer

Podcast: High Omega-3, Low Omega-6 Diet with Fish Oil ... William Aronson: So we found that the Ki67 index increased by 24% in the control group and decreased by 15% in the low omega-6, high omega-3 ...

4. nature.com nature.com/articles/s41391-023-00745-4

Effect of omega-3 fatty acid diet on prostate cancer ... Thus, dietary ω-3 FAs may have the potential to reduce intra-tumoral androgen levels in prostate cancer through inhibition of M2 macrophage ...

5. uclahealth.org uclahealth.org/news/release/low-omega-6-omega-3-rich-diet-and-fish-oil-may-slow-prostate

A low omega-6, omega-3 rich diet and fish oil may slow ... A diet low in omega-6 and high in omega-3 fatty acids, combined with fish oil supplements, significantly reduced the growth rate of prostate cancer cells in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6179880/

Do Omega-3 Fatty Acids Cause Prostate Cancer? - PMC A more thorough overview of the pertinent literature suggests that increased omega-3 fatty acid consumption does not increase prostate cancer risk, and notably ...

7. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(13)01000-8/fulltext

Omega-3 and Prostate Cancer: Examining the Pertinent ... dietary consumption of long-chain omega-3 fatty acids—from fish or fish oil supplements—may increase the risk of prostate cancer ...

8. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.24.00608

High Omega-3, Low Omega-6 Diet With Fish Oil for Men ... A high omega-3, low omega-6 diet with FO for 1 year resulted in a significant reduction in Ki-67 index, a biomarker for prostate cancer progression, metastasis ...

9. lipid.org lipid.org/communications/lipidspin/2014POTPOURRI/11

Omega-3 Fatty Acids and Prostate Cancer - A Study "Spun" ... The answer is no. Eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA) levels were 3.52% in the no-cancer control group, 3.67% in the lowgrade cancer group ...