Nutrition and Exercise Advice for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Must be taking: Androgen deprivation therapy

Disqualifiers: COPD, Heart disease, Heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how personalized nutrition and exercise plans can help prostate cancer patients on hormone therapy reduce frailty linked to obesity. Participants will receive a tailored diet (dietary intervention), engage in a home exercise program (exercise intervention), and attend monthly educational meetings (educational intervention). The goal is to determine if these interventions can improve overall health and alter blood markers related to muscle health. This trial suits men with prostate cancer who are currently on hormone therapy and can walk unassisted for at least 100 meters (about 200 steps). As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for many.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these interventions are safe for prostate cancer patients?

Research shows that dietary changes are generally safe for prostate cancer patients. Studies have found that a low-fat diet can slow the growth of prostate cancer cells, with no major side effects reported. Patients in past trials managed these diets well.

Exercise programs that include both aerobic activities (like walking) and resistance exercises (like weight lifting) are also well-received. Research suggests these exercises can improve quality of life and fitness without causing harm, safely reducing the side effects of prostate cancer treatments.

Educational programs, which involve learning about prostate cancer and health, have proven effective without any safety concerns. These programs can increase knowledge and promote healthy habits.

Overall, existing research considers these interventions—diet, exercise, and education—safe for prostate cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how a combination of diet, exercise, and education can support prostate cancer patients, offering an alternative to traditional treatments like surgery, radiation, or hormone therapy. Unlike conventional approaches that primarily target the cancer cells directly, this method focuses on enhancing overall well-being and potentially improving quality of life. The personalized diet plan, tailored exercise regimen, and monthly educational meetings aim to empower patients to take an active role in their health, which could lead to better outcomes and increased patient satisfaction. This holistic approach could redefine how supportive care is integrated into cancer treatment.

What evidence suggests that these nutrition and exercise interventions could be effective for prostate cancer survivors?

This trial will evaluate the impact of a combined approach involving dietary, exercise, and educational interventions for prostate cancer. Research has shown that dietary changes can help manage prostate cancer by influencing growth factors. One study found that a low-fat diet might slow the growth of prostate cancer cells. For exercise, combining activities like walking or cycling with strength training can enhance the overall well-being and health of men with prostate cancer. Studies also suggest that exercise can boost physical abilities and mental sharpness, which are important during cancer treatment. Educational programs about prostate cancer can help patients understand their condition better, encouraging them to take an active role in their care and decisions, leading to improved health. ^{1 3 4 6 7}

Who Is on the Research Team?

Gurkamal Chatta, Dr.

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for prostate cancer survivors who are overweight or obese and have been on androgen deprivation therapy for less than 5 years. They must be able to walk, have normal liver function, not be receiving other cancer treatments like chemo, and can't have severe heart or lung conditions.

Inclusion Criteria

Creatinine < 1.5 x upper limit of normal (ULN), AST or ALT <2 x ULN within 6 months prior to enrollment

You have a high body mass index (BMI), indicating that you are overweight or obese.

I have been on hormone therapy for less than 5 years.

Exclusion Criteria

You have certain orthopedic, musculoskeletal or psychological conditions that may limit your participation (decided by the doctor).

Your doctor thinks that you are too weak or frail to participate in the study.

Unwilling or unable to follow protocol requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an individualized diet plan and complete a home-based exercise program for 6 months, including aerobic and resistance exercises, and attend monthly educational meetings.

6 months

Monthly educational meetings

Follow-up

Participants are monitored for changes in body composition, muscle strength, and other health metrics after the intervention.

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Intervention
• Educational Intervention
• Exercise Intervention

Trial Overview The study tests if personalized nutrition advice and exercise programs can reduce obesity-related weakness in men treated with hormone therapy for prostate cancer. It also looks at changes in blood levels of muscle-related proteins (myokines).

How Is the Trial Designed?

Group I: Supportive care (diet, exercise, education) Experimental Treatment 5 Interventions

Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Published Research Related to This Trial

This study will compare the effectiveness of a telehealth-delivered exercise and nutrition program against a traditional clinic-based program in 104 overweight/obese men with prostate cancer, focusing on reducing fat mass while preserving muscle mass.

The trial aims to demonstrate that a remote intervention can be as effective as in-person supervision, making it more accessible for patients undergoing androgen deprivation therapy, which often leads to increased fat mass.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss for overweight and obese patients with prostate cancer: a study protocol of a randomised trial comparing clinic-based versus Telehealth delivered EXercise and nutrition intervention (the TelEX trial). Galvão, DA., Taaffe, DR., Hayne, D., et al.[2022]

A pilot study involving 52 men with prostate cancer showed a significant increase in nutrition knowledge after attending a seminar, with scores rising from 71.6% to 79.3%.

Participants found the nutrition education seminar satisfactory and expressed a desire for more integrative approaches to dietary information, suggesting that group education could be a cost-effective method for improving dietary knowledge in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Education Seminars for Prostate Cancer-Diet and Prostate Program: Evaluation and Recommendations (DAPPER Study). Stringer, EJ., Sidhu, S., Austin, K., et al.[2022]

Only a small percentage of long-term prostate cancer survivors (11.8% using diet and 7.8% using exercise) actively employed dietary changes or exercise to manage their condition, indicating a potential gap in awareness or utilization of these strategies.

Younger, more educated survivors, and those involved in support groups were more likely to adopt these lifestyle changes, suggesting that targeted counseling could enhance the use of diet and exercise to improve quality of life and cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with the use of diet and the use of exercise for prostate cancer by long-term survivors. Hughes, S., Egger, S., Carle, C., et al.[2020]

A supervised exercise training intervention integrated into standard prostate cancer care was feasible and well-accepted, with 79% of eligible participants (36 out of 45) receiving the intervention despite COVID-19 lockdowns.

Participants engaged in an average of 27 minutes of aerobic exercise per session, achieving 92% of their target heart rate, and completed the program without serious adverse events, indicating the safety and potential benefits of exercise in managing the side effects of androgen deprivation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial). Reale, S., Turner, RR., Sutton, E., et al.[2021]

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]

The Prostate 8-II trial is a 4-arm randomized controlled trial involving 200 men with prostate cancer, aiming to assess the effects of exercise and diet interventions on cancer recurrence and patient quality of life over a 24-month period after radical prostatectomy.

Participants are assigned to one of four groups (exercise-only, diet-only, exercise + diet, or usual care) and will receive various resources and support to help achieve their health goals, with the primary focus on measuring biochemical recurrence and secondary outcomes related to tumor biomarkers and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a 4-arm randomized controlled trial testing remotely delivered exercise-only, diet-only, and exercise + diet interventions among men with prostate cancer treated with radical prostatectomy (Prostate 8-II). Van Blarigan, EL., Chan, JM., Sanchez, A., et al.[2023]

The study demonstrated that a web-based behavioral intervention for men with prostate cancer is feasible and acceptable, with a high follow-up rate of 82.7% at 3 months and 77.2% at 6 months among 202 participants.

Participants who received the most comprehensive intervention (level 4) showed small improvements in diet and physical activity compared to those in the least intensive group (level 1), indicating that more tailored support may enhance health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial. Chan, JM., Van Blarigan, EL., Langlais, CS., et al.[2021]

A study involving 14 men from diverse racial and ethnic backgrounds highlighted the importance of understanding patients' social contexts, motivations, and preparedness for lifestyle changes to improve diet and exercise interventions for men with advanced prostate cancer.

Recommendations for future mobile health (mHealth) interventions include tailoring programs to individual needs based on their home environment, access to resources, and health literacy, which can enhance engagement and effectiveness in promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Men of Diverse Racial and Ethnic Groups With Advanced Prostate Cancer in the Design of an mHealth Diet and Exercise Intervention: Focus Group Study. Wang, EY., Borno, HT., Washington Iii, SL., et al.[2023]

A qualitative study involving 20 men with prostate cancer on androgen deprivation therapy (ADT) revealed that common side effects like weight gain and loss of muscle negatively impact their body image and masculinity, highlighting the need for effective dietary interventions.

Participants expressed a strong demand for specialized nutrition services to help manage ADT side effects, but faced barriers such as high costs and unclear referral pathways, indicating a significant gap in accessible nutrition support for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition services during prostate cancer androgen deprivation therapy. Baguley, B., Smith-Gillis, C., Porter, J., et al.[2023]

Citations

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Nutrition, dietary interventions and prostate cancer Growth inhibitory effect of low fat diet on prostate cancer cells: results of a prospective, randomized dietary intervention trial in men with prostate cancer.

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

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Effect of a Behavioral Intervention to Increase Vegetable ... A behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression among men with early-stage ...

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Nutrition and Diet in the Prevention and Management of ... This study aims to analyze global scientific evidence regarding the role of diet in the prevention and management of prostate cancer.