Exercise Program for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Christina M Dieli-Conwright, PhD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

Must be taking: Androgen deprivation

Must not be taking: Chemotherapy

Disqualifiers: Unstable bone lesions, other malignancies, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether a 16-week supervised, clinic-based circuit training intervention utilizing resistance and functional exercises and self-directed aerobic exercise will improve frailty and sarcopenic status and disease progression outcomes among pre-frail/frail metastatic prostate cancer patients receiving androgen deprivation therapy (ADT). The names of the study intervention involved in this study is: • Supervised circuit training (aerobic and resistance exercise regimen)

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 must be on androgen deprivation therapy and cannot be receiving chemotherapy or treatment for other active cancers, except for basal cell carcinoma.

What data supports the effectiveness of the treatment Supervised Circuit Training, Exercise Therapy, Physical Therapy, Rehabilitation Exercise for prostate cancer?

Research shows that exercise, including resistance and endurance training, can improve quality of life, muscle strength, and cardiovascular health in prostate cancer patients, especially those undergoing androgen-deprivation therapy. These exercises help manage treatment side effects like muscle loss and depression, and may also slow disease progression.

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Is exercise safe for prostate cancer patients?

Exercise, including resistance and endurance training, is generally safe for prostate cancer patients, even those undergoing androgen deprivation therapy, and can help manage treatment side effects like muscle loss and cardiovascular issues.

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How is the Supervised Circuit Training treatment for prostate cancer different from other treatments?

Supervised Circuit Training is unique because it focuses on improving physical function and quality of life through a combination of endurance and resistance exercises, even for prostate cancer patients with bone metastases, who are often excluded from exercise programs due to fracture risks. This approach helps counteract muscle loss and functional impairments caused by androgen deprivation therapy and other cancer treatments.

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Eligibility Criteria

The FIERCE Trial is for English-speaking men over 18 with metastatic prostate cancer who are pre-frail or frail and on ADT. They must be willing to travel to Dana-Farber Cancer Institute, have physician clearance for exercise, and not already doing much structured exercise.

Inclusion Criteria

Have physician's clearance to participate in exercise

Willing to travel to Dana-Farber Cancer Institute for necessary data collection and exercise sessions

I have been diagnosed with prostate cancer that has spread.

Exclusion Criteria

You have been doing specific resistance exercises at least twice a week and moderate-to-intense aerobic exercises for at least an hour a week. Doing too much extra exercise could make it hard to see the effects of the study exercise program.

I am currently undergoing chemotherapy for issues related to androgen deprivation therapy.

I have bone lesions that are at high risk of fractures.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants partake in a 16-week supervised exercise program or continue with normal activities

16 weeks

Weekly supervised exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Participant Groups

This study tests a 16-week supervised circuit training program combining resistance and functional exercises with self-directed aerobic activity. It aims to see if this can improve frailty, sarcopenia (muscle loss), and disease progression in patients.

Group I: Exercise Group Experimental Treatment 1 Intervention

Participants will partake in a 16-week supervised exercise program.

Group II: Attention Control Group Experimental Treatment 1 Intervention

Participants will continue with their normal daily activities.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Beth Israel Deaconess Medical Center Boston, MA

Brigham and Women's Hospital Boston, MA

Dana-Farber Cancer Institute Boston, MA

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute Lead Sponsor

Prostate Cancer Foundation Collaborator

References

1. 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] Physical exercise has been shown to be an effective, safe, and quite inexpensive method to reduce cardiovascular and metabolic risk factors and is currently in the process of establishing its relevance for cancer specific morbidity and mortality. The aim of this systematic review was to focus on specific effects of resistance exercise (RE) in the adjuvant therapy and rehabilitation of prostate cancer patients (PCaPs) receiving or having received androgen deprivation therapy (ADT).

2. Belgium pubmed.ncbi.nlm.nih.gov

[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.

3. Germany pubmed.ncbi.nlm.nih.gov

Supported progressive resistance exercise training to counter the adverse side effects of robot-assisted radical prostatectomy: a randomised controlled trial. [2021] To investigate the effects of a supported home-based progressive resistance exercise training (RET) programme on indices of cardiovascular health, muscular strength and health-related quality of life (HR-QoL) in prostate cancer (PCa) patients after treatment with robot-assisted radical prostatectomy (RARP).

4. 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] 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).

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

What Should We Tell Patients About Physical Activity After a Prostate Cancer Diagnosis? [2020] A number of observational studies and clinical trials have shown that physical activity after a diagnosis of prostate cancer is associated with a decrease in disease progression and an increase in survival, and that specific exercises reduce morbidity from prostate cancer treatments. However, providers need more guidance on what types of physical activity to recommend to patients across different disease states and treatments in prostate cancer, and when and how to initiate the discussion. In addition to evaluating important studies showing benefits of physical activity in patients with prostate cancer, this review suggests some evidence-based methods for incorporating physical activity interventions into clinical practice.

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial. [2022] The presence of bone metastases has excluded participation of prostate cancer patients in exercise intervention studies to date and is also a relative contraindication to supervised exercise in the community setting because of concerns of fragility fracture. However, this group of patients often have developed significant muscle atrophy and functional impairments from prior and continuing androgen deprivation that is exacerbated by subsequent and more intensive interventions such as chemotherapy. The aim of this study is to determine the efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases.

7. Germany pubmed.ncbi.nlm.nih.gov

The role of exercise in the management of adverse effects of androgen deprivation therapy for prostate cancer: a rapid review. [2021] Prostate cancer (PCa) is the most commonly diagnosed cancer in Australia, accounting for one quarter of all new cancer diagnoses for males. Androgen deprivation therapy (ADT) is the standard first-line therapy for metastatic PCa but is also used across much of the spectrum of disease. Unfortunately, debilitating adverse effects are a significant and largely unavoidable feature of ADT. A recent systematic review of adverse effects of ADT identified 19 sub-groups classified according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The potential for multiple simultaneous adverse effects, their associated management and the impact of adverse effects on cancer outcomes and quality of life are important considerations in the treatment and supportive care of men with PCa. Exercise is increasingly being recognized as an efficacious strategy in managing these adverse effects.

8. 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] 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.

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

Fitness outcomes from a randomised controlled trial of exercise training for men with prostate cancer: the ENGAGE study. [2022] The main purpose of this study was to investigate the effects of a 12-week, clinician-referred, community-based exercise training program with supervised and unsupervised sessions for men with prostate cancer. The secondary purpose was to determine whether androgen deprivation therapy (ADT) modified responses to exercise training.

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

Attention to the principles of exercise training in exercise studies on prostate cancer survivors: a systematic review. [2020] The purpose of this review is to update previously published reviews on exercise programming in exercise trials in prostate cancer survivors. We evaluated: 1) the application of the principles of exercise training in prescribed programs; 2) the reporting of the components of the exercise prescription; and 3) the reporting of adherence of participants to the prescribed programs.

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

Exercise Preserves Physical Function in Prostate Cancer Patients with Bone Metastases. [2022] The presence of bone metastases has excluded participation of cancer patients in exercise interventions and is a relative contraindication to supervised exercise in the community setting because of concerns of fragility fracture. We examined the efficacy and safety of a modular multimodal exercise program in prostate cancer patients with bone metastases.