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

Trial Summary

What is the purpose of this trial?

This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer survivors. Individualized nutrition and exercise advice for prostate cancer patients on androgen deprivation therapy may help to reduce obese frailty and change the levels of myokines in blood.

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 data supports the effectiveness of the treatment Nutrition and Exercise Advice for Prostate Cancer?

Research shows that diet and exercise interventions can help men with prostate cancer lose weight and improve their quality of life. A systematic review found that diet, alone or combined with exercise, led to significant weight loss, which is important for better health outcomes. ^{1 2 3 4 5}

Is the Nutrition and Exercise Advice for Prostate Cancer treatment safe for humans?

The studies show that nutrition and exercise interventions for prostate cancer patients, including those undergoing androgen deprivation therapy, are generally safe and well-tolerated. Participants in these studies did not experience serious adverse events, indicating that these interventions are safe for humans. ^{3 5 6 7 8}

How does the Nutrition and Exercise Advice treatment for prostate cancer differ from other treatments?

This treatment is unique because it combines dietary changes, exercise, and education to help manage prostate cancer, focusing on improving quality of life and potentially reducing cancer progression by maintaining a healthy weight. Unlike traditional treatments that may focus solely on medication or surgery, this approach emphasizes lifestyle changes to support overall health and well-being. ^{1 3 4 5 9}

Research Team

Gurkamal Chatta, Dr.

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

References

1. Canada 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. [2021]

2. Canada 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. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Nutrition Education Seminars for Prostate Cancer-Diet and Prostate Program: Evaluation and Recommendations (DAPPER Study). [2022]

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

The effect of dietary and exercise interventions on body weight in prostate cancer patients: a systematic review. [2022]

5. United States 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). [2023]

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

Nutrition services during prostate cancer androgen deprivation therapy. [2023]

7. England 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). [2022]

8. England 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). [2021]

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

Factors associated with the use of diet and the use of exercise for prostate cancer by long-term survivors. [2020]