Exercise Program + Fitbit Monitoring for Prostate Cancer

Overseen By Christopher J Logothetis

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: GnRH agonists/antagonists

Must not be taking: Chemotherapy, investigational products

Disqualifiers: Heart disease, symptomatic bone metastasis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well an exercise program and continuous Fitbit monitoring work for managing metabolic syndrome and cardiovascular disease risk in patients with prostate cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and does not response to treatment (refractory) and are receiving androgen deprivation therapy. Balancing treatment efficacy, drug side effects, and competing comorbidities with prostate cancer is essential. This trial is being done to learn if an exercise program can help to improve metabolic syndrome and cardiovascular (heart) fitness in prostate cancer patients who are receiving androgen deprivation therapy.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it allows the use of certain prostate cancer treatments like GnRH agonists/antagonists, abiraterone, enzalutamide, bisphosphonates, or RANK-ligand inhibitors. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Exercise Program + Fitbit Monitoring for Prostate Cancer?

Research shows that supervised exercise programs can improve physical fitness, quality of life, and reduce some side effects in prostate cancer patients, especially those on hormone therapy. Using a Fitbit to track activity might help patients stay motivated and engaged in their exercise routines. ^{1 2 3 4 5}

Is the exercise program with Fitbit monitoring safe for prostate cancer patients?

The exercise program, which includes aerobic and resistance training, has been shown to be safe for prostate cancer patients undergoing androgen deprivation therapy, with no serious adverse events reported in studies. ^{3 5 6 7 8}

How is the Exercise Program + Fitbit Monitoring treatment different from other treatments for prostate cancer?

This treatment is unique because it combines an exercise program with Fitbit monitoring to improve health outcomes for prostate cancer patients, focusing on physical activity rather than medication. It aims to enhance quality of life and physical function, which is different from traditional treatments like androgen deprivation therapy that can have adverse effects on muscle and bone health. ^{1 3 5 9 10}

Research Team

Christopher Logothetis

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for men with metastatic or recurrent prostate cancer that's resistant to treatment and are on hormone therapy. They should be able to perform physical activities, have stable disease, and not be undergoing certain other treatments. Participants need a smartphone and must speak English.

Inclusion Criteria

My platelet count is at least 75,000 without transfusions in the last 3 months.

Able to speak and comprehend English

My cancer has spread, as shown by scans, or it came back after surgery or radiation.

Exclusion Criteria

I have bone pain due to cancer spread.

I haven't had chemotherapy in the last 28 days.

I do not have serious heart conditions that would make exercise unsafe.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 16-week exercise program with continuous Fitbit monitoring to manage metabolic syndrome and cardiovascular risk

16 weeks

Regular exercise sessions, Fitbit monitoring daily

Follow-up

Participants are monitored for cardiovascular fitness and metabolic syndrome severity post-intervention

12 weeks

Treatment Details

Interventions

• Exercise Intervention
• FitBit

Trial Overview The study tests if an exercise program along with continuous Fitbit monitoring can manage metabolic syndrome and reduce heart disease risk in prostate cancer patients on hormone therapy. It includes quality-of-life assessments, questionnaires, and educational components.

Participant Groups

Group I: Group II (exercise program FitBit) Experimental Treatment 4 Interventions

Patients participate in supervised and self-directed exercise sessions over 60 minutes BIW for up to 16 weeks. Patients also wear a FitBit daily over 16 weeks.

Group II: Group I (education exercise packet, FitBit) Active Control 4 Interventions

Patients receive general education exercise packet with instruction to exercise regularly for up to 150 minutes weekly. Patients also wear a FitBit daily over 16 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

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]

A six-month supervised exercise program significantly improved physical performance, muscular strength, and quality of life in 27 prostate cancer patients undergoing androgen deprivation therapy.

The exercise program was well tolerated and highlighted the need for screening cardio-metabolic risk factors in these patients, as they initially presented with an unfavorable cardio-metabolic profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a six-month supervised physical exercise program on physical and cardio-metabolic profile and quality of life in patients with prostate cancer on androgen deprivation therapy: a pilot and feasibility study. Zabegalina, NS., Henderickx, MMEL., Lamotte, V., 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]

Only 16% of men with prostate cancer receiving androgen deprivation therapy (ADT) discussed exercise with their clinicians, despite 36.7% expressing interest in a supervised exercise program, highlighting a significant gap in supportive care.

Common barriers to exercise participation included fatigue and treatment-related weakness, while clinicians identified limited time and patient safety concerns as obstacles to discussing exercise, indicating a need for better education and integration of exercise specialists in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as a supportive care strategy in men with prostate cancer receiving androgen deprivation therapy at a regional cancer centre: a survey of patients and clinicians. Elbourne, H., Soo, WK., O'Reilly, V., et al.[2022]

Men with prostate cancer participating in supervised exercise programs reported significant physiological and psychological health benefits, including reduced treatment-related side effects and improved self-efficacy.

The study highlights the importance of support from exercise physiologists and peer connections in enhancing engagement and ongoing participation in exercise, suggesting these elements are crucial for developing effective supportive care programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative exploration of the experience of men with prostate cancer involved in supervised exercise programs. Cormie, P., Turner, B., Kaczmarek, E., et al.[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]

A 6-month exercise program combining aerobic and resistance training significantly improved cardiorespiratory capacity and body composition in 97 men undergoing androgen deprivation therapy for prostate cancer.

Participants in the exercise group showed notable improvements in fat oxidation and glucose levels, along with increases in lean mass and decreases in total and trunk fat mass, highlighting the potential benefits of exercise during hormone suppression treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Improves V˙O2max and Body Composition in Androgen Deprivation Therapy-treated Prostate Cancer Patients. Wall, BA., GALVãO, DA., Fatehee, N., et al.[2018]

A 6-month feasibility trial involving 24 prostate cancer patients undergoing androgen deprivation therapy (ADT) aims to compare the effects of resistance vs. aerobic exercise on cardiometabolic health and quality of life.

The study will assess various outcomes including recruitment, retention, adherence, and safety, which will help inform the design of a larger trial focused on optimizing exercise interventions for patients on ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of aerobic- and resistance-emphasised exercise on cardiometabolic health and quality of life in men receiving androgen deprivation therapy for prostate cancer: Protocol for a feasibility trial. Murphy, K., Kehoe, B., Denieffe, S., et al.[2023]

A pilot randomized controlled trial involving 25 men with metastatic castrate-resistant prostate cancer (mCRPC) demonstrated that remotely monitored exercise training is feasible, safe, and acceptable, with 82% of participants completing the 12-week program.

Participants showed high adherence to the exercise regimen, completing 90% of aerobic and 96% of resistance training sessions, and reported high satisfaction with the program, indicating strong potential for future studies on exercise's impact on clinical outcomes in this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and acceptability of a remotely monitored exercise pilot CHAMP: A Clinical trial of High-intensity Aerobic and resistance exercise for Metastatic castrate-resistant Prostate cancer. Kenfield, SA., Van Blarigan, EL., Panchal, N., et al.[2022]

The 'Football Club (FC) Prostate' study is a randomized trial involving 80 men undergoing androgen deprivation therapy (ADT) for advanced prostate cancer, aiming to evaluate the effects of soccer training on various health outcomes over a 12-week period.

The primary focus is on changes in lean body mass, with secondary outcomes including cardiovascular function and patient-reported quality of life, potentially demonstrating that soccer training can be a safe and effective rehabilitation strategy for men receiving ADT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the 'FC Prostate' randomized controlled trial. Uth, J., Schmidt, JF., Christensen, JF., et al.[2021]

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. Poland pubmed.ncbi.nlm.nih.gov

Effects of a six-month supervised physical exercise program on physical and cardio-metabolic profile and quality of life in patients with prostate cancer on androgen deprivation therapy: a pilot and feasibility study. [2022]

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. Germany pubmed.ncbi.nlm.nih.gov

Exercise as a supportive care strategy in men with prostate cancer receiving androgen deprivation therapy at a regional cancer centre: a survey of patients and clinicians. [2022]

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

A qualitative exploration of the experience of men with prostate cancer involved in supervised exercise programs. [2022]

6. 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]

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

Exercise Improves V˙O2max and Body Composition in Androgen Deprivation Therapy-treated Prostate Cancer Patients. [2018]

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

A comparison of aerobic- and resistance-emphasised exercise on cardiometabolic health and quality of life in men receiving androgen deprivation therapy for prostate cancer: Protocol for a feasibility trial. [2023]

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

Feasibility, safety, and acceptability of a remotely monitored exercise pilot CHAMP: A Clinical trial of High-intensity Aerobic and resistance exercise for Metastatic castrate-resistant Prostate cancer. [2022]

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

Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the 'FC Prostate' randomized controlled trial. [2021]