Anti-inflammatory Diet for Prostate Cancer

Recruiting at 1 trial location

Overseen By Tatiana Diacova, PhD, MS, RDN

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must be taking: Androgen deprivation therapy

Disqualifiers: Diabetes, Hypertension, Cardiovascular, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how a specific low-calorie, anti-inflammatory diet affects men with metastatic prostate cancer undergoing androgen deprivation therapy (ADT), focusing on differences between African American and non-Hispanic white men. The goal is to determine if the diet can reduce body fat, improve heart health markers, and enhance overall quality of life. Participants will maintain their regular diet for three months, then switch to the special diet while walking three times a week. Men who have been on ADT for over a year and are expected to continue for at least six more months may qualify if they also have a BMI over 25. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could improve quality of life for future patients.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since participants must continue androgen deprivation therapy (ADT) during the study, you will likely need to stay on that medication.

What prior data suggests that this dietary intervention is safe for participants?

Research has shown that a low-calorie, anti-inflammatory diet is generally safe. Studies have found that these diets, which aim to reduce inflammation, are usually well-tolerated. They often include fruits, vegetables, whole grains, and healthy fats, which are safe and beneficial for most people.

Evidence also suggests that these diets can lower the risk of certain cancers, such as prostate cancer. Specifically, certain foods and nutrients in these diets contain antioxidants, which may help protect cells from damage. Importantly, past research has not identified any major negative effects from these diets.

In summary, the low-calorie, anti-inflammatory diet being tested is based on foods widely considered safe and part of a healthy eating plan. This suggests it is well-tolerated with minimal risks for those who follow it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional prostate cancer treatments that often involve surgery, radiation, or hormone therapy, the hypocaloric anti-inflammatory diet is unique because it focuses on dietary changes to potentially affect cancer progression. This approach targets inflammation, a process that can contribute to cancer growth, by using specific foods to reduce inflammatory responses in the body. Researchers are excited about this treatment because it offers a non-invasive, lifestyle-based alternative that could complement existing therapies, potentially improving patient outcomes without the side effects associated with more aggressive treatments.

What evidence suggests that a hypocaloric anti-inflammatory diet might be effective for prostate cancer?

This trial will compare a hypocaloric anti-inflammatory diet with a habitual dietary and physical activity regimen. Studies have shown that a low-calorie diet focused on reducing inflammation can lower inflammation and improve health in prostate cancer patients. Research suggests that certain foods and nutrients, especially those rich in antioxidants, may decrease the risk of prostate cancer. Reviews have found that dietary changes can improve heart health indicators like cholesterol and blood pressure in men with prostate cancer. Additionally, a diet that reduces inflammation might improve survival rates for those with aggressive prostate cancer. Overall, an anti-inflammatory diet could help reduce body fat, improve heart health, and enhance quality of life for men undergoing prostate cancer treatment. ^{1 2 4 6 7}

Who Is on the Research Team?

Zhaoping Li, MD, PhD

Principal Investigator

University of California, Los Angeles

Matthew Rettig, MD

Principal Investigator

Greater Los Angeles Division of Veterans Affairs, Los Angeles, California 90073

Are You a Good Fit for This Trial?

This trial is for African American and non-Hispanic white men with metastatic prostate cancer who are undergoing ADT therapy. Participants will be observed on their usual diet, then switch to a special low-calorie, anti-inflammatory diet combined with walking exercise.

Inclusion Criteria

I will continue hormone therapy for more than 6 months after starting the study.

I have read and signed the consent form for this study.

Serum testosterone <50 ng/dL

Exclusion Criteria

I have diabetes or another serious condition like uncontrolled high blood pressure, liver, kidney, or heart disease.

Life expectancy < 1 year

Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessment of participants' habitual diet and activity level

1 week

Phase 1: Habitual Diet and Activity

Participants maintain their habitual dietary and physical activity regimen

12 weeks

1 visit (in-person) at the end of phase

Phase 2: Hypocaloric Anti-inflammatory Diet

Participants follow a hypocaloric (-500 kcal), anti-inflammatory diet and walk for 1 hour on 3 days per week

12 weeks

1 visit (in-person) at the end of phase

Follow-up

Participants are monitored for changes in fat mass, cardiovascular risk factors, and quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hypocaloric Anti-Inflammatory Diet

Trial Overview The study tests the impact of a calorie-restricted, anti-inflammatory diet and regular walking on fat mass, cardiovascular risk factors, inflammatory markers, fatigue levels, and quality of life in men of different races on ADT for prostate cancer.

How Is the Trial Designed?

Group I: Hypocaloric anti-inflammatory diet Experimental Treatment 1 Intervention

Participants will follow a hypocaloric anti-inflammatory diet for the last 3 months of the study.

Group II: Habitual dietary and physical activity regimen Active Control 1 Intervention

Participants will maintain their habitual dietary and physical activity regimen for the first 3 months of the study.

Hypocaloric Anti-Inflammatory Diet is already approved in United States, European Union for the following indications:

Approved in United States as Hypocaloric Anti-Inflammatory Diet for:

• Management of cardiovascular risk factors in men undergoing androgen deprivation therapy (ADT) for prostate cancer

Approved in European Union as Hypocaloric Anti-Inflammatory Diet for:

• Supportive care for men with prostate cancer undergoing ADT to reduce cardiovascular morbidity

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Comprehensive Cancer Network

Collaborator

Trials

121

Recruited

7,400+

Published Research Related to This Trial

The meta-analysis of six studies found that a pro-inflammatory diet, as indicated by a high Dietary Inflammatory Index (DII), is associated with a 74% increased risk of developing prostate cancer compared to a more anti-inflammatory diet.

For every one-point increase in the DII score, the risk of prostate cancer rises by 9%, suggesting that adopting a diet rich in anti-inflammatory foods like whole grains, fish, and vegetables may help reduce this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between Dietary Inflammatory Index and the Risk of Prostate Cancer: A Meta-Analysis. Mohseni, R., Abbasi, S., Mohseni, F., et al.[2020]

In a 6-month clinical trial with 45 men who had prostate cancer, a low-carbohydrate diet significantly reduced the intestinal permeability marker zonulin, suggesting improved gut health.

Weight loss was associated with a longer prostate-specific antigen doubling time (PSADT), indicating that greater weight loss may slow prostate cancer progression, although zonulin was not a significant mediator in this relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss via a low-carbohydrate diet improved the intestinal permeability marker, zonulin, in prostate cancer patients. Lin, PH., Howard, L., Freedland, SJ.[2022]

A 6-month randomized trial involving 45 patients with biochemical recurrence of prostate cancer showed that a low-carbohydrate diet (LCD) led to significant weight loss and metabolic improvements without adversely affecting PSA doubling time (PSADT), which remained similar between the LCD and control groups.

Exploratory analysis suggested that the LCD may actually be associated with a longer PSADT (28 months) compared to the control group (13 months), indicating potential benefits for disease progression that warrant further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a 6-Month Low-Carbohydrate Intervention on Disease Progression in Men with Recurrent Prostate Cancer: Carbohydrate and Prostate Study 2 (CAPS2). Freedland, SJ., Allen, J., Jarman, A., et al.[2022]

In a study involving 20 overweight men undergoing prostatectomy, those who participated in a weight loss program lost over 5% of their body weight, which led to significant improvements in their Dietary Inflammatory Index (DII) scores, indicating reduced dietary inflammation.

The weight loss intervention was associated with changes in prostate tissue biomarkers and gene expression, suggesting that intentional weight loss may positively influence biological mechanisms related to prostate cancer progression, although further research is needed to understand the clinical implications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploration of biomarkers from a pilot weight management study for men undergoing radical prostatectomy. Dimachkie, MD., Bechtel, MD., Robertson, HL., et al.[2022]

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]

In a study of 254 prostate cancer cases and 328 controls, a pro-inflammatory diet was found to be more common among Black men and was associated with an increased risk of high-grade prostate cancer, suggesting dietary factors may contribute to racial disparities in cancer outcomes.

Despite the association with high-grade prostate cancer, the study found no significant link between pro-inflammatory diet scores and overall prostate cancer risk or low-grade prostate cancer, indicating that the impact of diet may vary by cancer severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary inflammatory index (DII) and risk of prostate cancer in a case-control study among Black and White US Veteran men. Vidal, AC., Oyekunle, T., Howard, LE., et al.[2022]

In a study of 15,296 men, adherence to the Western dietary pattern was associated with an increased risk of aggressive prostate cancer, particularly for Gleason grade group >6 and ISUP grade 3 + 4 + 5 tumors.

No protective effect against prostate cancer was found for the Prudent and Mediterranean dietary patterns, suggesting that simply following these diets may not be sufficient to prevent the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High adherence to Western dietary pattern and prostate cancer risk: findings from the EPIC-Spain cohort. Castelló, A., Rodríguez-Barranco, M., Pérez-Gómez, B., et al.[2023]

In a case-control study involving 394 prostate cancer patients and 794 matched controls, no significant association was found between a pro-inflammatory diet (measured by the energy-adjusted dietary inflammatory index) and overall prostate cancer risk or aggressiveness.

The study suggests that a pro-inflammatory diet may not be linked to prostate cancer risk or severity, but it calls for further research with larger sample sizes to explore this relationship more thoroughly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary inflammatory index and prostate cancer risk in a case-control study in Mexico. Vázquez-Salas, RA., Shivappa, N., Galván-Portillo, M., et al.[2019]

In a study of 2,056 men with nonmetastatic prostate cancer, higher scores on dietary indices associated with inflammation and insulin resistance were linked to an increased risk of prostate cancer progression, suggesting that diet may influence cancer outcomes.

The findings indicate that adopting dietary patterns that reduce inflammation and insulin levels could potentially improve survivorship for men with prostate cancer, although no direct link to prostate cancer-specific mortality was found.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postdiagnostic Inflammatory, Hyperinsulinemic, and Insulin-Resistant Diets and Lifestyles and the Risk of Prostate Cancer Progression and Mortality. Langlais, CS., Graff, RE., Van Blarigan, EL., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-prostate-cancer-metastatic-disease-2-2024-c937e

Anti-inflammatory Diet for Prostate Cancer The Hypocaloric Anti-Inflammatory Diet is unique because it focuses on reducing inflammation through dietary changes, potentially affecting prostate cancer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12251742/

Nutrition and Diet in the Prevention and Management of ... Several foods and nutrients have demonstrated potential benefits in reducing the risk of prostate cancer, primarily due to their antioxidant, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0378512224000355

Review article The effect of dietary interventions or patterns ... This review synthesizes the evidence on the effect of dietary interventions on cardiometabolic biomarkers and cardiovascular disease risk in prostate cancer ...

4. urologytimes.com urologytimes.com/view/systematic-review-highlights-diet-s-role-in-prostate-cancer-outcomes

Systematic review highlights diet's role in prostate cancer ... Still, the overall takeaway is that adopting balanced, plant-forward, and anti-inflammatory diets may support better prostate cancer prevention ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5585016/

Dietary inflammatory index and prostate cancer survival - PMC These study findings suggest that diet, through its inflammatory potential, may play a role in survival after PCa diagnosis among men with more aggressive, poor ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1279770724003129

The association of the dietary inflammatory potential with ... A low-inflammatory diet is associated with decreased risk and prolonged onset time of rectal cancer and lung cancer, especially among males and individuals ...

7. mdpi.com mdpi.com/2072-6643/17/3/503

Dietary Restrictions and Cancer Prevention: State of the Art Between 30 and 50 percent of all tumors are known to be preventable by eating a healthy diet, staying active, avoiding alcohol, smoking, and being overweight.