~20 spots leftby May 2029

Nutrition and Exercise Advice for Prostate Cancer

Gurkamal Chatta MD | Roswell Park ...
Overseen byGurkamal Chatta, Dr.
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Roswell Park Cancer Institute
Must be taking: Androgen deprivation therapy
Disqualifiers: COPD, Heart disease, Heart failure, others
No Placebo Group

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.12345

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.35678

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.13459

Research Team

Gurkamal Chatta MD | Roswell Park ...

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.
See 7 more

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
See 4 more

Trial 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 (Procedure)
  • Educational Intervention (Behavioral Intervention)
  • Exercise Intervention (Behavioral Intervention)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Supportive care (diet, exercise, education)Experimental Treatment5 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.

Find a Clinic Near You

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

References

Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial. [2021]
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]
Nutrition Education Seminars for Prostate Cancer-Diet and Prostate Program: Evaluation and Recommendations (DAPPER Study). [2022]
The effect of dietary and exercise interventions on body weight in prostate cancer patients: a systematic review. [2022]
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]
Nutrition services during prostate cancer androgen deprivation therapy. [2023]
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]
Embedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial). [2021]
Factors associated with the use of diet and the use of exercise for prostate cancer by long-term survivors. [2020]