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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a lifestyle program called EMPOWER can slow prostate cancer progression in men whose cancer has returned after initial treatment. EMPOWER helps participants lose weight through diet and exercise changes, with support provided remotely via phone and email. Participants must have a history of recurrent prostate cancer and be willing to try diet and exercise changes to lose weight. As an unphased trial, this study offers participants the chance to contribute to innovative research that may enhance future cancer care.

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 prior data suggests that the EMPOWER intervention is safe for weight loss in prostate cancer patients?

Research shows that the EMPOWER program is a lifestyle plan designed to help people lose weight. The program aims for participants to lose at least 5% of their starting weight within six months by focusing on healthy eating and regular exercise. Studies have found that this type of program is generally safe and easy to follow. Initially, participants attend weekly coaching sessions, which become less frequent over time. Support is provided remotely through phone calls and emails, eliminating the need for in-person meetings.

The available research reports no serious side effects linked to the EMPOWER program. Generally, changes to diet and exercise routines are considered low-risk. However, as with any new program, it is important to monitor how the body feels and consult a healthcare professional if any concerns arise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EMPOWER program for prostate cancer because it offers a fresh approach to weight management through a multichannel, behavioral lifestyle intervention. Unlike conventional treatments that might focus solely on medication or surgery, EMPOWER emphasizes remote coaching and digital tools to help men achieve and maintain a 5% weight loss over time. This program stands out by using a web-based system for self-monitoring diet, exercise, and weight, allowing for personalized feedback without requiring in-person visits. By integrating technology and behavioral strategies, EMPOWER aims to improve health outcomes in a way that's convenient and tailored to each participant.

What evidence suggests that the EMPOWER intervention is effective for reducing prostate cancer progression?

This trial will compare the EMPOWER lifestyle program with standard care for men with prostate cancer. Studies have shown that the EMPOWER lifestyle program can lead to significant weight loss in these patients. Research indicates that programs like EMPOWER, which emphasize healthy eating and regular exercise, can help slow cancer progression. Previous participants in similar programs lost weight and maintained it over time. These findings suggest that the EMPOWER program might help slow prostate cancer in men whose cancer has returned after initial treatment. The program is delivered remotely, providing convenient and easy access. ^{5 6 7 8 9}

Who Is on the Research Team?

Corinne Joshu, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04266431

EMPOWER Men to Reduce Weight and Inhibit Prostate ... This study will evaluate whether a lifestyle intervention focused on weight loss, EMPOWER, reduces prostate cancer progression at 12 months among men with ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-01918

Behavioral Lifestyle Intervention (EMPOWER) in Reducing ... This trial studies how well a behavioral lifestyle intervention (EMPOWER) works in reducing prostate cancer progression in patients with prostate cancer.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10969418/

PC-PEP, a Comprehensive Daily Six-Month Home-Based ... A comprehensive daily six-month home-based patient empowerment program leads to weight loss in men with prostate cancer.

4. withpower.com withpower.com/trial/phase-prostatic-neoplasms-1-2020-19e62

EMPOWER Weight-Loss Program for Prostate Cancer 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.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38534960/

PC-PEP, a Comprehensive Daily Six-Month Home-Based ... PC-PEP led to significant weight loss in men undergoing curative prostate cancer treatment compared to standard-of-care.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6617585/

Enhancing & Mobilizing the POtential for Wellness & ... The EMPOWER study is unique in its application of evidence-based psychotherapy targeting peritraumatic stress to improve patient and caregiver ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/59/NCT03276559/Prot_SAP_001.pdf

Enhancing & Mobilizing the Potential for Wellness & ... Examine the effects of EMPOWER on patient outcomes, including intensity of care and quality of life/quality of. Page 6. Enhancing & Mobilizing the Potential for ...

8. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3515-0

Enhancing & Mobilizing the POtential for Wellness ... - Trials The EMPOWER study is unique in its application of evidence-based psychotherapy targeting peritraumatic stress to improve patient and caregiver ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36822969/

A Comprehensive 6-mo Prostate Cancer Patient ... The aim of this study was to examine the effects of a 6-mo online home-based physical, mental, and social support intervention, the Prostate Cancer Patient ...