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

Trial Summary

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 data supports the effectiveness of the treatment Hypocaloric Anti-Inflammatory Diet for prostate cancer?

Research suggests that diets reducing inflammation, like those rich in omega-3 fatty acids, may help slow prostate cancer progression by modulating the body's immune response. Additionally, weight loss, which can be achieved through a low-calorie diet, may reduce inflammation and improve outcomes for prostate cancer patients. ^{1 2 3 4 5}

Is the anti-inflammatory diet safe for humans?

The research does not provide specific safety data for the anti-inflammatory diet in humans, but studies on similar diets, like low-carbohydrate diets, have shown they can be safe and may improve health markers in prostate cancer patients. ^{1 3 6 7 8}

How is the Hypocaloric Anti-Inflammatory Diet treatment different from other prostate cancer treatments?

The Hypocaloric Anti-Inflammatory Diet is unique because it focuses on reducing inflammation through dietary changes, potentially affecting prostate cancer progression by altering inflammatory and insulin pathways, unlike traditional treatments that may involve medication or surgery. ^{1 2 3 7 9}

What is the purpose of this trial?

There is a well-documented association between androgen deprivation therapy (ADT) and cardiovascular morbidity. A majority of men on ADT gain weight contributing to an increase in cardiovascular risk factors (CVRFs) and cardiovascular morbidity. Dietary intervention combined with exercise have shown success in reducing weight/fat mass and improving cardiovascular risk factors (CVRF). There is little data on whether African American men would respond to diet and exercise interventions differently from non-Hispanic white men. We will conduct a pilot, controlled two-phase intervention study stratified by race to investigate the following objectives: 1. Compare effect of a hypocaloric, anti-inflammatory diet on changes in fat mass between African- American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy. 2. Compare effect of a hypocaloric, anti-inflammatory diet on changes in cardiovascular risk factors (body weight, lean body mass, waist-to-height ratio, blood pressure, lipids and HbA1C) and inflammatory markers (hs-CRP and cytokines) between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy. 3. Compare effect of a hypocaloric, anti-inflammatory diet on changes in cancer-related fatigue and quality of life between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy. We will enroll 35 African American and 35 non-Hispanic white men with prostate cancer undergoing ADT therapy. In phase 1, after baseline assessment, men will consume their habitual diet and continue their habitual activity level for 3 months. During phase 2, participants will be instructed to consume a hypocaloric (-500 kcal), anti- inflammatory diet and walk for 1 hour on 3 days per week for 3 months. At baseline, after phase 1 and 2 primary outcome (fat mass) and secondary outcomes (CVRF and inflammatory markers) and tertiary outcomes (cancer-related fatigue and quality of life) will be determined.

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

Eligibility Criteria

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.

Any subject who currently uses tobacco products

Any use of >20 g of alcohol per day

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Dietary inflammatory index and prostate cancer risk in a case-control study in Mexico. [2019]

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

Postdiagnostic Inflammatory, Hyperinsulinemic, and Insulin-Resistant Diets and Lifestyles and the Risk of Prostate Cancer Progression and Mortality. [2023]

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

Exploration of biomarkers from a pilot weight management study for men undergoing radical prostatectomy. [2022]

5. United States 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). [2022]

6. England pubmed.ncbi.nlm.nih.gov

Weight loss via a low-carbohydrate diet improved the intestinal permeability marker, zonulin, in prostate cancer patients. [2022]

7. England 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. [2022]

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

High adherence to Western dietary pattern and prostate cancer risk: findings from the EPIC-Spain cohort. [2023]

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

Association between Dietary Inflammatory Index and the Risk of Prostate Cancer: A Meta-Analysis. [2020]