Exercise Program + Fitbit Monitoring for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
No Placebo Group
Prior Safety Data
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.
What safety data exists for exercise programs in prostate cancer treatment?The studies reviewed indicate that supervised exercise programs, including aerobic and resistance training, are generally safe for prostate cancer patients undergoing androgen deprivation therapy. The STAMINA trial specifically reported no serious adverse events during the intervention, which involved aerobic and resistance exercises. The exercise programs were well-received by participants and showed improvements in various health metrics, suggesting that they can be safely integrated into prostate cancer care.236710
Is the Exercise Intervention a promising treatment for prostate cancer?Yes, the Exercise Intervention is promising for prostate cancer. It can improve quality of life, help with body and heart health, and may even increase survival rates. It also helps manage side effects of other treatments.12469
What data supports the idea that Exercise Program + Fitbit Monitoring for Prostate Cancer is an effective treatment?The available research shows that exercise programs, including aerobic and resistance training, can improve the quality of life and physical health of prostate cancer patients. For example, one study found that a six-month supervised exercise program led to better muscle endurance, improved heart and lung fitness, and reduced depression in patients. Another study suggested that exercise might help increase survival rates for those with advanced prostate cancer. These findings indicate that exercise, especially when monitored with tools like Fitbit, can be a beneficial treatment for prostate cancer patients.24568
Do I have to stop taking my current medications for this trial?The trial does not specify if you need to stop taking your current medications. However, you cannot use any other systemic therapy for prostate cancer except for certain allowed medications like GnRH agonists/antagonists, abiraterone, enzalutamide, bisphosphonates, or RANK-ligand inhibitors.
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
I can complete a strenuous exercise test under a doctor's supervision.
My platelet count is at least 75,000 without transfusions in the last 3 months.
My cancer has spread, as shown by scans, or it came back after surgery or radiation.
My hemoglobin level is 9.0 g/dL or higher without transfusions in the last 3 months.
I expect to have low testosterone levels for at least the next 6 months.
I can take care of myself and am up and about more than half of my waking hours.
My prostate cancer was confirmed by a lab test.
Exclusion Criteria
I do not have serious heart conditions that would make exercise unsafe.
I have bone pain due to cancer spread.
I do not have any active cancer other than prostate cancer.
I have untreated spinal cord issues causing symptoms.
I haven't been able to walk 400 meters or do arm and leg exercises in the last 3 months.
I have had radiation or surgery for bone metastasis before.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (exercise program FitBit)Experimental Treatment4 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 Control4 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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the 'FC Prostate' randomized controlled trial. [2021]Androgen deprivation therapy (ADT) is a cornerstone in the treatment of advanced prostate cancer. Adverse musculoskeletal and cardiovascular effects of ADT are widely reported and investigations into the potential of exercise to ameliorate the effects of treatment are warranted. The 'Football Club (FC) Prostate' study is a randomized trial comparing the effects of soccer training with standard treatment approaches on body composition, cardiovascular function, physical function parameters, glucose tolerance, bone health, and patient-reported outcomes in men undergoing ADT for prostate cancer.
A qualitative exploration of the experience of men with prostate cancer involved in supervised exercise programs. [2022]To provide an in-depth description of the experience of supervised exercise programs among men with prostate cancer and to identify elements critical to optimizing engagement and ongoing exercise participation.
Exercise Improves V˙O2max and Body Composition in Androgen Deprivation Therapy-treated Prostate Cancer Patients. [2018]Prostate cancer is the most common cancer in men, and patients treated with androgen deprivation therapy (ADT) experience unfavorable changes in body composition and associated metabolic complications, which can increase the risk of cardiovascular disease. We examined the effect of a 6-month program of aerobic and resistance exercise aimed at improving body composition and cardiorespiratory health in this population.
Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. [2022]Preliminary evidence supports the beneficial role of physical activity on prostate cancer outcomes. This phase III randomised controlled trial (RCT) is designed to determine if supervised high-intensity aerobic and resistance exercise increases overall survival (OS) in patients with metastatic castrate-resistant prostate cancer (mCRPC).
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]To evaluate the effect of a six-month supervised physical exercise program on the physical and cardio-metabolic profile and quality of life in patients with prostate cancer on androgen deprivation therapy.
[Evaluation of a supervised six-month exercise program in patients with prostate cancer receiving androgen-deprivation therapy]. [2019]Prostate cancer is the most common cancer in men in Belgium. Its treatment is mainly based on androgen-deprivation therapy, which is accompanied by some adverse effects (e.g., sarcopenic obesity, osteoporosis). We evaluated the benefits of a supervised exercise program combining endurance and resistance training on these adverse events, patient participation, and quality of life in twenty-seven prostate cancer patients treated with androgen-deprivation therapy. We observed a significant improvement in systolic blood pressure, quadriceps and hamstrings muscular endurance, cardiorespiratory endurance, distance in the six-minute walk test and depression.
Embedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial). [2021]Lifestyle interventions involving exercise training offset the adverse effects of androgen deprivation therapy in men with prostate cancer. Yet provision of integrated exercise pathways in cancer care is sparse. This study assessed the feasibility and acceptability of an embedded supervised exercise training intervention into standard prostate cancer care in a single-arm, multicentre prospective cohort study. Feasibility included recruitment, retention, adherence, fidelity and safety. Acceptability of behaviourally informed healthcare and exercise professional training was assessed qualitatively. Despite the imposition of lockdown for the COVID-19 pandemic, referral rates into and adherence to, the intervention was high. Of the 45 men eligible for participation, 79% (n = 36) received the intervention and 47% (n = 21) completed the intervention before a government mandated national lockdown was enforced in the United Kingdom. Patients completed a mean of 27 min of aerobic exercise per session (SD = 3.48), at 77% heart rate maximum (92% of target dose), and 3 sets of 10 reps of 3 resistance exercises twice weekly for 12 weeks, without serious adverse event. The intervention was delivered by 26 healthcare professionals and 16 exercise trainers with moderate to high fidelity, and the intervention was deemed highly acceptable to patients. The impact of societal changes due to the pandemic on the delivery of this face-to-face intervention remain uncertain but positive impacts of embedding exercise provision into prostate cancer care warrant long-term investigation.
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]To understand how frequently exercise is discussed and/or prescribed as a supportive care measure and the barriers and facilitators to exercise uptake for men with prostate cancer receiving androgen deprivation therapy (ADT) at a regional cancer centre.
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]Exercise may improve clinical and quality of life outcomes for men with prostate cancer. No randomized controlled trials (RCTs) have examined the feasibility, safety, and acceptability of remote exercise training in men with metastatic castrate-resistant prostate cancer (mCRPC).
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]Those with intermediate and high-risk prostate cancer typically receive androgen deprivation therapy (ADT) as part of their treatment. ADT often results in extensive side effects including increased risk of cardiometabolic disease. Many ADT side effects can be influenced by exercise, both resistance and aerobic training. Exercise regimes typically combine aerobic and resistance exercise but the appropriate emphasis for achieving the broadest range of therapeutic benefits has yet to be determined. We propose to determine the feasibility of undertaking a larger trial comparing a resistance- vs an aerobic-emphasised exercise intervention in men with prostate cancer undergoing ADT. The trial will also investigate preliminary evidence of difference between arms for cardiometabolic health and quality of life outcomes.