Lifestyle Changes for Prostate Cancer

Overseen By Dalnim Cho

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunotherapy, Hormonal therapy, Chemotherapy, Radiation

Disqualifiers: Metastatic cancer, Active malignancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how lifestyle changes can improve the quality of life for African American prostate cancer survivors and their partners. Participants will either follow an exercise and nutrition plan with coaching (Exercise Intervention) or receive information on healthy living (Informational Intervention). The goal is to determine if these changes can enhance physical activity, improve diet, and reduce inflammation. Ideal candidates are African American prostate cancer survivors who have completed treatment and are not currently active or involved in another lifestyle program. Participants must enroll with a spouse or romantic partner who also seeks to become more active. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the well-being of many in the future.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have planned treatments like immunotherapy, hormonal therapy, chemotherapy, or radiation during the study.

What prior data suggests that this lifestyle intervention is safe for prostate cancer patients and their partners?

Research has shown that exercise is generally safe for men with prostate cancer. Studies indicate that both aerobic exercises, such as walking, and resistance exercises, like weight lifting, are well-tolerated. These exercises can help manage the side effects of prostate cancer and its treatments. Reports suggest that these activities do not cause harmful side effects and may even improve bone health and overall well-being.

In general, supervised exercise programs are recommended. A professional guides the activities, making them safer and more effective. Evidence supports the safety of exercise for prostate cancer patients, and participants usually handle these activities without major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring lifestyle changes for prostate cancer because they offer a holistic approach that involves patients and their partners, potentially enhancing the quality of life and overall health. Unlike conventional treatments like surgery, radiation, or hormone therapy, this method emphasizes exercise and nutrition counseling, which are non-invasive and focus on sustainable health improvements. The inclusion of family members in coaching calls and nutrition sessions introduces a unique family-centered care model, which could improve adherence and long-term health outcomes. Additionally, interviewing healthcare providers about family-focused care might reveal insights into how these supportive measures can enhance existing treatment strategies.

What evidence suggests that this trial's lifestyle interventions could be effective for reducing prostate cancer disparities?

Research shows that exercise can benefit men with prostate cancer. In this trial, participants in Group I will receive an exercise plan, coaching calls, and nutrition counseling. Studies have found that combining strength exercises with activities that improve heart and lung fitness can greatly enhance quality of life, particularly in overall health and mental sharpness. One study discovered that exercise improved sexual function in prostate cancer patients compared to those who did not exercise. Overall, exercise programs have led to clear improvements in both physical and mental health for these patients. These findings suggest that lifestyle changes like exercise could boost health and quality of life for African American prostate cancer patients and their partners. ^{2 3 6 7 8}

Who Is on the Research Team?

Dalnim Cho, PhD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for African American prostate cancer survivors who've finished therapy, and their spouses or partners. Participants must be underactive in physical activity, not involved in other lifestyle programs, and have internet access. Partners must live together without major health issues. Healthcare providers treating prostate cancer are also eligible.

Inclusion Criteria

Spouses or romantic partners must live together with the survivors

Spouses or romantic partners must enroll with a spouse or a romantic partner with prostate cancer

Spouses or romantic partners must not have major health problems (e.g., cancer, dementia, stroke, and heart and lung diseases)

Exclusion Criteria

My partner and I have not both enrolled in protocol #2017-0556.

My spouse or partner and I can both understand and speak English.

I am a prostate cancer survivor not planning any cancer treatment during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants and their partners receive an exercise plan, coaching calls, and nutrition counseling over 6 months

6 months

Coaching calls every 2 weeks, 2 nutrition counseling sessions

Follow-up

Participants are monitored for quality of life, physical activity, nutrient intake, and inflammation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention
• Informational Intervention
• Interview
• Nutritional Assessment
• Questionnaire Administration
• Telephone-Based Intervention

Trial Overview

The study tests a lifestyle intervention to see if it helps improve the quality of life, partner support, physical activity levels, diet habits, and reduces inflammation among African American men with prostate cancer and their partners.

How Is the Trial Designed?

Group I: Provider Interviews (interviews) Experimental Treatment 1 Intervention

Healthcare providers participate in an interview regarding their opinions on family-focused care and its ability to improve health behaviors.

Group II: Group I (exercise plan, coaching calls, nutrition counseling) Experimental Treatment 5 Interventions

Patients and their partners receive an exercise plan and printed materials that includes instructions for walking or other moderate-intensity activities. Patients and their partners also receive coaching calls discussing physical activity and diet related questions, each lasting 45-60 minutes and occurring every 2 weeks for 6 months. In addition, patients and their partners complete 2 nutrition counseling sessions over 1 hour each at baseline and before month 3 with an MD Anderson registered dietitian.

Group III: Group II (physical activity/healthy eating information) Active Control 2 Interventions

Patients and their partners receive information/materials regarding physical activity and healthy eating.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Brander Beacons Cancer Research

Collaborator

Trials

1

Recruited

6+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Resistance exercise (RE) is shown to be a safe and effective method to improve muscular strength, performance, fatigue, and quality of life in prostate cancer patients undergoing androgen deprivation therapy, based on a systematic review of studies published until September 2014.

While RE has clear benefits for physical performance and quality of life, the evidence regarding its effects on cardiovascular performance, body composition, and other health markers remains inconclusive, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of resistance exercise on physical performance and health-related quality of life in prostate cancer patients: a systematic review. Hasenoehrl, T., Keilani, M., Sedghi Komanadj, T., et al.[2022]

A study of 40 Italian men newly diagnosed with prostate cancer revealed that while 65% reported being physically active, over half did not meet recommended exercise levels, indicating a need for improved physical activity among this group.

Despite many participants being aware of their unhealthy habits, such as high alcohol consumption and being overweight, most were unwilling to change their lifestyle, highlighting the importance of healthcare professionals to encourage motivation for healthier behaviors during this critical time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise habits, lifestyle behaviors, and motivation to change among men with prostate cancer: a cross-sectional study. Bressi, B., Iotti, C., Cagliari, M., et al.[2022]

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]

Exercise interventions, including aerobic and resistance training, are safe for men undergoing androgen-deprivation therapy for prostate cancer and can improve muscular strength, cardiorespiratory fitness, functional performance, and reduce fatigue.

While exercise shows promise in mitigating some adverse effects of treatment, the effects on bone health, cardiometabolic risk, and quality of life remain unclear, indicating a need for further high-quality research to establish specific exercise guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on treatment-related adverse effects for patients with prostate cancer receiving androgen-deprivation therapy: a systematic review. Gardner, JR., Livingston, PM., Fraser, SF.[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]

This phase III randomized controlled trial involves 866 participants with metastatic castrate-resistant prostate cancer (mCRPC) to assess whether supervised high-intensity aerobic and resistance exercise can improve overall survival compared to self-directed exercise.

The study will also explore the relationship between exercise and various health factors, such as immune function and metabolic biomarkers, which may help understand how exercise impacts survival outcomes in mCRPC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. Newton, RU., Kenfield, SA., Hart, NH., et al.[2022]

A systematic review of 21 trials involving 1748 prostate cancer patients found that resistance exercise significantly improved body composition, functional capacity, and muscle strength, with a notable reduction in fat mass and an increase in lean mass.

The study suggests that lower volume resistance training at moderate to high intensity is just as effective as higher volume training, which may help make exercise more accessible and encourage adherence among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. Lopez, P., Taaffe, DR., Newton, RU., 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]

Citations

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This study aimed to determine the feasibility of an aerobic-emphasised (AE) versus a resistance-emphasised (RE) exercise intervention in men with prostate ...

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The results show that combining strength and aerobic exercise significantly improves quality of life, especially in general health, mental clarity, and sexual ...

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In this randomized clinical trial including 112 patients with prostate cancer, exercise improved erectile function compared with usual care.

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