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

6 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well a lifestyle intervention works in reducing prostate cancer disparities among African American prostate cancer patients and their spouses or romantic partners. A lifestyle intervention may help researchers learn if social support can help African American prostate cancer patients and their partners improve their quality of life, support from their partner, physical activity, diet, and inflammation.

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 data supports the effectiveness of the treatment Lifestyle Changes for Prostate Cancer?

Research shows that physical activity, including aerobic and resistance exercise, can improve quality of life and reduce disease progression in prostate cancer patients. Exercise has been linked to better survival rates and reduced adverse effects from treatments like androgen-deprivation therapy. ^{1 2 3 4 5}

Is exercise safe for prostate cancer patients?

Exercise programs, including resistance and aerobic training, have been shown to be safe for prostate cancer patients, even those undergoing androgen-deprivation therapy, with no serious adverse events reported in studies. ^{3 5 6 7 8}

How is the Exercise Intervention treatment for prostate cancer different from other treatments?

The Exercise Intervention for prostate cancer is unique because it focuses on physical activity, such as aerobic and resistance training, to improve health outcomes and reduce side effects of traditional treatments like androgen deprivation therapy, rather than using medication. This approach can help improve muscle strength, cardiovascular health, and overall quality of life, which are not typically addressed by standard drug treatments. ^{3 9 10 11 12}

Research Team

Dalnim Cho, PhD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

My spouse or romantic partner is 18 years old or older.

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

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 do not have any active cancer other than in my prostate.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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 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]

References

1. England 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. [2022]

2. 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]

3. Belgium pubmed.ncbi.nlm.nih.gov

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

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of a 2-year home-based endurance training intervention on physiological function and PSA doubling time in prostate cancer patients. [2018]

5. Germany 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. [2022]

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

Resistance Exercise Dosage in Men with Prostate Cancer: Systematic Review, Meta-analysis, and Meta-regression. [2023]

7. 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]

8. United States 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. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Physical exercise habits, lifestyle behaviors, and motivation to change among men with prostate cancer: a cross-sectional study. [2022]

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

Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP) is associated with improvement in weight and components of metabolic syndrome in men exposed to androgen deprivation therapy for prostate cancer. [2023]

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

Educational tool-kit on diet and exercise: survey of prostate cancer patients about to receive androgen deprivation therapy. [2015]

12. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review of dietary, nutritional, and physical activity interventions for the prevention of prostate cancer progression and mortality. [2023]