EMPOWER Weight-Loss Program for Prostate Cancer

Overseen By Eryka Wentz, MA

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Corticosteroids, Lithium, Antipsychotics

Disqualifiers: Metastatic disease, Recent MI, others

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

Compensation: Varies

Number of Visits: 12

Duration: 24 months

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test if a weight loss program called EMPOWER can slow down prostate cancer in men whose cancer has returned after initial treatment. The goal is to delay the spread of cancer and avoid harsh treatments. Weight loss might help slow cancer growth, improving overall health without significant side effects.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have used prescription weight loss medication or certain other medications that affect weight within the past 6 months.

What data supports the effectiveness of the EMPOWER Weight-Loss Program for Prostate Cancer treatment?

Research suggests that self-help diet and physical activity interventions with support can lead to modest but sustained weight loss in men treated for prostate cancer, which may help in managing the disease. Additionally, empowering patients through personalized approaches and technology-driven interventions can improve their quality of life and support weight management efforts. ^{1 2 3 4 5}

Is the EMPOWER Weight-Loss Program for Prostate Cancer safe for humans?

The studies reviewed suggest that weight loss interventions, including exercise and nutrition programs, are generally safe for men with prostate cancer, as they improve physical function and quality of life without significant adverse effects. ^{3 4 6 7 8}

How does the EMPOWER Weight-Loss Program for Prostate Cancer differ from other treatments?

The EMPOWER Weight-Loss Program is unique because it combines online education, physical activities, a mostly plant-based diet, stress reduction, and social support to empower prostate cancer patients, focusing on both mental and physical health, unlike traditional treatments that may not address these aspects comprehensively. ^{2 4 9 10 11}

Research Team

Corinne Joshu, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

Men with prostate cancer that's come back after treatment, who are overweight (BMI >= 25), can use the internet regularly, and have a stable health status. They should be willing to change their lifestyle and must not have had any major cardiovascular events recently or be on weight loss drugs or certain other medications.

Inclusion Criteria

I am a man who either can't have or chose not to have further radiation after surgery, or I had a recurrence within 3 years after salvage radiation.

I can do all my daily activities without help.

You are open to making changes in your diet, physical activity, and weight.

Exclusion Criteria

I cannot exercise regularly due to a heart condition or other medical issue.

I haven't had a heart attack, stroke, or heart disease treatment in the last 6 months.

I don't have a condition that makes it hard to measure my weight or where losing weight would be harmful.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the EMPOWER lifestyle intervention or standard of care

24 months

Weekly contacts for 12 weeks, then monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• EMPOWER

Trial Overview The EMPOWER trial is testing if a special program focused on losing weight can slow down prostate cancer progression in men whose cancer has returned. Participants will either join this program or receive standard care, decided randomly.

Participant Groups

Group I: EMPOWER Experimental Treatment 1 Intervention

EMPOWER is a multichannel, behavioral lifestyle intervention delivered remotely. The goals of EMPOWER are to induce a loss of 5% or more of initial weight within 6 months and to maintain these improvements at 12 and 24 months, by meeting dietary and physical activity goals. Coach-participant contacts will occur by phone and email, without in-person visits. Coaching contacts will be weekly for the first 12 weeks and then monthly thereafter. Men will have access to a web-based system that (1) provides support for behavioral methods of weight management and (2) allows coaches to review participant self-monitoring data and monitor participant progress towards goals. Men will record diet, exercise, and weight on the web or on a smart phone application.

Group II: Standard of Care Active Control 1 Intervention

Men randomized to the standard of care group will continue to receive treatment from the mens' medical oncologist. These men will also be provided with a one page informative brochure on lifestyle recommendations adapted from the American Cancer Society Prostate Cancer Survivorship Care Guidelines, at the time of randomization. At the end of the trial, men in this arm will be offered a one-time counseling session with an intervention coach on healthy lifestyle.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Maryland Cigarette Restitution Fund

Collaborator

Trials

10

Recruited

900+

Findings from Research

Many prostate cancer patients feel they have limited opportunities to communicate with their healthcare providers, which can affect their sense of empowerment during treatment.

Patients expressed a need for better support in decision-making and self-management, especially after diagnosis and surgery, highlighting the importance of personalized care and social support in enhancing their empowerment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Qualitative Investigation on Patient Empowerment in Prostate Cancer. Renzi, C., Fioretti, C., Oliveri, S., et al.[2020]

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]

A supervised exercise program combining endurance and resistance training significantly improved various health markers in 27 prostate cancer patients undergoing androgen-deprivation therapy, including muscular endurance and cardiorespiratory fitness.

Participants also experienced improvements in quality of life, as evidenced by better performance in the six-minute walk test and reduced depression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. Caty, G., Salazar Gajardo, S., Butoescu, V., et al.[2019]

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]

The 28-day Prostate Cancer-Patient Empowerment Program (PC-PEP) was well-received by 30 prostate cancer patients, who rated its usefulness at 9 out of 10, indicating its effectiveness in promoting both mental and physical health.

Participants appreciated the comprehensive nature of the program, which included education, physical activities, and social support, suggesting that integrating PC-PEP into standard care from the start of diagnosis could enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Efficacy of a 28-Day Comprehensive Online Prostate Cancer Patient Empowerment Program (PC-PEP) in Facilitating Engagement of Prostate Cancer Patients in Their Survivorship Care: A Qualitative Study. Ilie, G., MacDonald, C., Richman, H., et al.[2023]

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]

References

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

Obesity does not adversely affect health-related quality-of-life outcomes after anatomic retropubic radical prostatectomy. [2015]

2. Switzerland pubmed.ncbi.nlm.nih.gov

A Qualitative Investigation on Patient Empowerment in Prostate Cancer. [2020]

3. England 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. [2020]

4. Canada pubmed.ncbi.nlm.nih.gov

Weight Management to Reduce Prostate Cancer Risk: A Survey of Men's Needs and Interests. [2020]

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

Interventions for Improving Body Composition in Men with Prostate Cancer: A Systematic Review and Network Meta-analysis. [2023]

6. Belgium pubmed.ncbi.nlm.nih.gov

[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. [2019]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Maintaining Weight Loss in Obese Men with Prostate Cancer Following a Supervised Exercise and Nutrition Program-A Pilot Study. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Assessing the Efficacy of a 28-Day Comprehensive Online Prostate Cancer Patient Empowerment Program (PC-PEP) in Facilitating Engagement of Prostate Cancer Patients in Their Survivorship Care: A Qualitative Study. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Living with prostate cancer: randomised controlled trial of a multimodal supportive care intervention for men with prostate cancer. [2021]

11. 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]