Weight Loss Interventions for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Must not be taking: Weight loss medications

Disqualifiers: Heart attack, Stroke, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best weight loss strategy for men with low-risk prostate cancer who are under close monitoring. It compares two approaches: intermittent fasting (not eating for set periods) and continuous calorie reduction (eating less regularly). The goal is to determine which method better reduces cancer progression and improves overall health. Men with prostate cancer under active surveillance, a BMI of 25 or higher, not on weight loss drugs, and without significant recent weight loss might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance health strategies for men with prostate cancer.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on weight loss medications to participate.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not be on weight loss medications.

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

Research has shown that intermittent fasting (IF) is generally manageable for most people. One study found that 70% of participants successfully fasted while undergoing cancer treatment. Fasting might also lower the risk of prostate cancer by affecting cancer cell growth and survival.

For continuous calorie energy reduction (CER), studies have found it can slow cancer growth. Individuals who have adjusted their diet for weight loss have found this method feasible. Both fasting and calorie reduction can aid in weight management and might reduce cancer risks.

Overall, fasting and calorie reduction appear safe for most people and may benefit prostate cancer patients. However, individual experiences can vary, so participants should consult their healthcare provider about any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these weight loss interventions for prostate cancer because they offer unique approaches compared to standard treatments like surgery, radiation, or hormone therapy. The intermittent fasting (IF) arm focuses on a novel dietary strategy where patients fast two days a week and follow National Cancer Institute (NCI) dietary guidelines on other days. This method is thought to potentially enhance weight management and improve metabolic health, which could positively impact cancer outcomes. The continuous energy restriction (CER) arm involves a structured weight loss plan with behavioral support, which could offer a more sustainable approach to managing weight. Both interventions emphasize remote learning and self-monitoring, making them accessible and potentially easier to integrate into daily life.

What evidence suggests that this trial's weight loss interventions could be effective for prostate cancer?

This trial will compare intermittent fasting (IF) with continuous calorie energy reduction (CER) as weight loss interventions for prostate cancer. Research has shown that intermittent fasting might help manage prostate cancer. Studies have found that fasting every other day lowers certain nutrients and proteins in prostate cancer tumors, potentially slowing their growth. Additionally, fasting for longer periods overnight is linked to a lower risk of developing prostate cancer. Conversely, continuous calorie reduction is a well-known weight loss method and has been tested in cancer survivors. This trial studies both fasting and calorie reduction for their potential to slow cancer progression in prostate cancer patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Karen Yeary

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for overweight or obese prostate cancer patients under active surveillance, with a BMI of at least 25. Participants must be adults who can walk unassisted, have not had significant weight loss or bariatric surgery recently, and are not on weight loss meds. They should understand English and the study's nature.

Inclusion Criteria

Free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component

English speaking

I have not had weight loss surgery in the past 10 years.

Exclusion Criteria

Unable to complete study measures in English

Unwilling or unable to follow protocol requirements

Adults who currently have type 1 or type 2 diabetes without medical clearance from their primary care physician to participate in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the CER or IF intervention, including remote lessons, self-monitoring, and blood sample collection

6 months

Regular remote sessions and in-person visits for blood sample collection

Follow-up

Participants are monitored for changes in prostate cancer progression, quality of life, and other health metrics

6 months

Follow-up clinic visits for assessments

What Are the Treatments Tested in This Trial?

Interventions

• Biospecimen Collection
• Dietary Intervention
• Fasting

Trial Overview The study tests whether intermittent fasting (IF) or continuous calorie energy reduction (CER) is more effective in reducing cancer progression in prostate cancer patients. It explores IF's potential benefits over CER due to metabolic changes alongside weight loss.

How Is the Trial Designed?

Group I: Arm II (IF) Experimental Treatment 3 Interventions

Patients undergo IF intervention consisting of remote lesson containing information and behavioral strategies about fasting, session with study interventionist to review lessons, and self-monitoring of body weight. Patients also undergo fasting 2 days per week and eat according to the NCI guidelines the remaining 5 days. Patients also undergo collection of blood samples throughout the trial.

Group II: Arm I (CER) Active Control 2 Interventions

Patients undergo CER intervention consisting of remote lesson containing information and behavioral strategies about weight loss, session with study interventionist to review lessons, and self-monitoring of body weight. Patients also undergo collection of blood samples throughout the trial.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Published Research Related to This Trial

Habitual continuous energy restriction (CER) has been shown to effectively prevent breast tumor formation in both animal studies and observational studies in women, while intermittent energy restriction (IER) and intermittent fasting (IF) may offer easier and potentially more effective alternatives for weight control and cancer prevention.

Animal studies suggest that IER and IF can reduce mammary tumor formation and may have different mechanisms of action compared to CER, including greater reductions in fat stores and improved insulin sensitivity, but more research is needed to directly compare these methods in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy restriction and the prevention of breast cancer. Harvie, M., Howell, A.[2013]

A 4-week study involving 48 overweight/obese adults showed that intermittent energy restriction (IER) led to a greater average weight loss of 4.57 kg compared to 2.46 kg with continuous energy restriction (CER), indicating IER may be more effective for weight loss when combined with high-intensity interval training (HIIT).

Both IER and CER resulted in improvements in body composition and cardiorespiratory fitness (CRF), but IER showed superior benefits in reducing body fat percentage and waist circumference compared to CER, suggesting it may be a more advantageous dietary approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential effects of intermittent energy restriction vs. continuous energy restriction combined high-intensity interval training on overweight/obese adults: A randomized controlled trial. Xu, R., Cao, YX., Chen, YT., et al.[2022]

A review of 32 studies, including 9 randomized controlled trials, found that certain dietary interventions, like a low-fat vegan diet and lycopene supplements, may help decrease prostate-specific antigen (PSA) levels in men with prostate cancer, suggesting potential benefits in slowing disease progression.

Only one trial reported a survival benefit associated with lycopene supplementation, highlighting the need for more robust studies to confirm these findings and better understand the impact of diet on prostate cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and dietary supplement intervention trials for the prevention of prostate cancer recurrence: a review of the randomized controlled trial evidence. Van Patten, CL., de Boer, JG., Tomlinson Guns, ES.[2008]

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]

A review of various studies suggests that a dietary intervention trial for prostate cancer patients should focus on reducing total fat intake to 15% of total calories.

The proposed diet should also include supplementation with selenium, vitamin E, and soya products, which may help in managing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition and prostate cancer: a proposal for dietary intervention. Wynder, EL., Rose, DP., Cohen, LA.[2023]

Current research on diet and prostate cancer is still evolving, with ongoing randomized controlled trials expected to provide clearer dietary recommendations in the future.

While specific dietary supplements and functional foods lack sufficient evidence for prostate cancer prevention or treatment, maintaining a healthy weight is crucial, as obesity is linked to worse outcomes and higher mortality rates from prostate cancer and cardiovascular diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary interventions in prostate cancer. Demark-Wahnefried, W.[2021]

A study involving 62 overweight or obese men with prostate cancer showed that a self-help diet and activity intervention with dietitian support led to a significant weight loss of approximately 2.13 kg at 12 weeks compared to a wait-list group.

The intervention also improved the participants' quality of life scores significantly at 12 weeks, indicating that lifestyle changes can have positive effects beyond just weight loss in men undergoing treatment for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A self-help diet and physical activity intervention with dietetic support for weight management in men treated for prostate cancer: pilot study of the Prostate Cancer Weight Management (PRO-MAN) randomised controlled trial. Mohamad, H., Ntessalen, M., Craig, LCA., et al.[2020]

Intermittent energy restriction (IER) has been shown in animal studies to be more effective than continuous energy restriction (CER) in reducing tumor rates, suggesting potential anticancer benefits.

Limited human studies indicate that IER may improve insulin sensitivity more than CER in overweight and obese individuals, but more long-term research is needed to confirm these findings and assess safety and efficacy in both overweight and normal-weight populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Could Intermittent Energy Restriction and Intermittent Fasting Reduce Rates of Cancer in Obese, Overweight, and Normal-Weight Subjects? A Summary of Evidence. Harvie, MN., Howell, T.[2023]

In a study involving 172 women undergoing chemotherapy, intermittent energy restriction (IER) showed a trend towards greater weight and body fat reduction compared to continuous energy restriction (CER), particularly after adjusting for body water.

While the overall incidence of severe chemotherapy toxicities was similar between IER and CER, there was a trend indicating fewer severe toxicities in the IER group during later cycles of treatment, suggesting IER may help reduce treatment-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer. Harvie, M., Pegington, M., Howell, SJ., et al.[2022]

In a pilot study involving 105 male SCID mice with prostate cancer, intermittent fasting regimens showed non-significant trends toward improved survival compared to a control group, suggesting potential benefits of fasting in cancer management.

Mice on certain fasting diets had significantly lower body weights and IGF-1 levels, indicating that these dietary interventions may influence cancer growth mechanisms, although no significant survival differences were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intermittent fasting with or without caloric restriction on prostate cancer growth and survival in SCID mice. Buschemeyer, WC., Klink, JC., Mavropoulos, JC., et al.[2010]

A diet-based intervention using telephone counselling significantly increased vegetable intake and plasma levels of beneficial carotenoids in 43 men with prostate cancer on active surveillance over 6 months.

The intervention led to substantial increases in the consumption of cruciferous vegetables and tomato products, suggesting a potential dietary approach to inhibit prostate cancer progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary modification in patients with prostate cancer on active surveillance: a randomized, multicentre feasibility study. Parsons, JK., Newman, VA., Mohler, JL., et al.[2015]

Recent studies indicate that very low-fat vegan diets and low-glycemic index diets can positively influence tumor biology in prostate cancer patients, potentially through mechanisms like weight loss.

Preclinical data suggest that both very low-fat and low-carbohydrate diets can slow tumor growth in mice, highlighting the need for larger clinical trials to confirm these effects in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary intervention strategies to modulate prostate cancer risk and prognosis. Freedland, SJ., Aronson, WJ.[2009]

A systematic review of 20 randomized controlled trials found that diet interventions, either alone or combined with exercise, can lead to significant weight loss in men treated for prostate cancer, with weight loss ranging from 0.8 kg to 6.1 kg.

Exercise alone did not result in weight loss, as most trials focused on improving fitness and quality of life rather than reducing body weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dietary and exercise interventions on body weight in prostate cancer patients: a systematic review. Mohamad, H., McNeill, G., Haseen, F., et al.[2022]

Citations

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Study: In Prostate Cancer, Intermittent Fasting Found to ... The results demonstrate that alternate-day fasting reduced amino acid levels and global protein synthesis within prostate cancer tumors, making ...

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Study Details | NCT05832086 | Intermittent Fasting Using a ... This study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to ...

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The Association of Nighttime Fasting Duration and Prostate ... The prostate cancer risk reduction with a prolonged nightly fast was moderately stronger among those individuals having their breakfast at 8:30 or before.

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Weight Loss Interventions to Reduce Cancer Progression ... This clinical trial examines weight loss interventions in reducing cancer progression in prostate cancer patients under active surveillance.

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Weight Loss Interventions for Prostate Cancer This clinical trial examines weight loss interventions in reducing cancer progression in prostate cancer patients under active surveillance.

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Energy and caloric restriction, and fasting and cancer Preclinical studies provided robust evidence that energy and caloric restrictions could hinder both cancer growth and progression.

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Dietary interventions to improve body composition in men ... In addition, the risk of prostate cancer recurrence after primary treatment reportedly increases by 21% per 5 kg*m−2 growth in BMI, suggesting a ...