Anti-inflammatory Diet for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byZhaoping Li, MD, PhD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Los Angeles
Must be taking: Androgen deprivation therapy
Disqualifiers: Diabetes, Hypertension, Cardiovascular, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
13678How 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.
12379Eligibility 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
+4 more
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
+6 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Hypocaloric anti-inflammatory dietExperimental Treatment1 Intervention
Participants will follow a hypocaloric anti-inflammatory diet for the last 3 months of the study.
Group II: Habitual dietary and physical activity regimenActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Greater Los Angeles Division of Veterans AffairsLos Angeles, CA
UCLA Health 200 Medical PlazaLos Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
National Comprehensive Cancer NetworkCollaborator
References
Dietary inflammatory index and prostate cancer risk in a case-control study in Mexico. [2019]Recent evidence suggests that a pro-inflammatory diet could be associated with prostate cancer (PC) risk. To evaluate the association between dietary inflammatory index (DII) and PC risk as well as aggressiveness, we conducted a case-control study in Mexico City. Cases were 394 individuals with incident, histologically confirmed PC, who were matched by age (±5 years) with 794 population controls. Dietary information was obtained through a semi-quantitative FFQ with a 3-year frame of reference before diagnosis, for cases, or interview, for controls. On the basis of twenty-eight food parameters, we estimated the energy-adjusted DII (E-DII). According to the Gleason score at diagnosis, PC cases were categorised as high (≥8), moderate (=7) and low (≤6) PC risk. Independent, unconditional logistic regression models adjusted for potential confounders were used to estimate PC risk and PC aggressiveness. There were no significant associations between overall PC risk and E-DII (OR3rd v. 1st tertile 1·18; 95 % CI 0·85, 1·63; P=0·33) or among men with high-risk PC (Gleason≥8) (OR 1·46; 95 % CI 0·88, 2·42; P=0·14). These results do not support the hypothesis that a pro-inflammatory diet is related to PC risk and PC aggressiveness. However, further studies with larger sample sizes, with sufficient statistical power and of varying designs should be conducted to address this hypothesis.
Postdiagnostic Inflammatory, Hyperinsulinemic, and Insulin-Resistant Diets and Lifestyles and the Risk of Prostate Cancer Progression and Mortality. [2023]Inflammatory and insulin pathways have been linked to prostate cancer; postdiagnostic behaviors activating these pathways may lead to poor outcomes. The empirical dietary inflammatory pattern (EDIP), empirical dietary index for hyperinsulinemia (EDIH), and empirical dietary index for insulin resistance (EDIR), and associated lifestyle indices (ELIH, ELIR) predict biomarkers of inflammation (EDIP: IL6, TNFaR2, CRP) and insulin secretion (EDIH/ELIH: c-peptide; EDIR/ELIR: TAG:HDL) from whole foods and behaviors.
Omega-3 fatty acids decrease prostate cancer progression associated with an anti-tumor immune response in eugonadal and castrated mice. [2019]Several lines of evidence suggest effects of dietary fat on prostate cancer (PCa) development and progression. Targeting omega (ω)-3:ω6 fatty acids (FA) ratio could be beneficial against PCa by favorably modulating inflammation. Here, we studied the effects of ω3- and ω6-enriched diets on prostate tumor growth and inflammatory response in androgen-deprived and non-deprived conditions.
Exploration of biomarkers from a pilot weight management study for men undergoing radical prostatectomy. [2022]Several biologic mechanisms, including inflammation and immune changes, have been proposed to explain the role of obesity in prostate cancer (CaP) progression. Compared to men of a healthy weight, overweight and obese men are more likely to have CaP recurrence post-prostatectomy. Obesity is related to inflammation and immune dysregulation; thus, weight loss may be an avenue to reduce inflammation and reverse these immune processes.
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]Both weight loss and low-carbohydrate diets (LCD) without weight loss prolong survival in prostate cancer models. Few human trials have tested weight loss or LCD on prostate cancer.
Weight loss via a low-carbohydrate diet improved the intestinal permeability marker, zonulin, in prostate cancer patients. [2022]Label="BACKGROUND">Accumulating evidence suggest that gut microbiota may impact urologic health including prostate cancer (PC), potentially via affecting intestinal permeability (IP). Studies have indicated that disrupted IP may be improved by healthy diets and weight loss. In the Carbohydrate and Prostate Study 2 (CAPS2) clinical trial, which showed that a low-carbohydrate diet (LCD) reduced weight significantly in men with PC and suggestively slowed PC disease progression, we explored the impact of LCD on an IP marker, zonulin and an inflammation marker, high sensitivity C-reactive protein (hsCRP).
Dietary inflammatory index (DII) and risk of prostate cancer in a case-control study among Black and White US Veteran men. [2022]We hypothesized a pro-inflammatory diet would be associated with higher prostate cancer (PC) risk.
High adherence to Western dietary pattern and prostate cancer risk: findings from the EPIC-Spain cohort. [2023]To explore the association between three previously identified dietary patterns (Western, Prudent and Mediterranean) and prostate cancer (PCa) risk by tumour aggressiveness.
Association between Dietary Inflammatory Index and the Risk of Prostate Cancer: A Meta-Analysis. [2020]Label="BACKGROUND">Diet is a known source of pro- and anti-inflammatory mediators, and inflammatory markers have been associated with mechanisms involved in prostate cancer initiation and progression. The Dietary Inflammatory Index (DII®) is a tool to assist researchers in determining the inflammatory potential of diet. The aim of this study was to conduct a meta-analysis to assess the association between DII and prostate cancer.