CHAMP: A Randomized Controlled Trial of High-intensity Aerobic and Resistance Exercise for Metastatic Prostate Cancer

NCT ID: NCT02613273

Last Updated: 2022-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-18
• Study Completion Date: 2022-06-30

Brief Summary

This Phase II, open-label, three-arm randomized controlled trial (RCT) will investigate the effects of 12 weeks of aerobic exercise vs. 12 weeks of resistance exercise vs. usual care in men with metastatic castration resistant prostate cancer to determine the safety, feasibility, and tolerance of exercise; quality of life indicators, and a prognostic score.

Detailed Description

This is a PI-initiated, randomized clinical trial of 12 weeks of aerobic exercise vs. 12 weeks of resistance exercise vs. usual care among 39 men with metastatic castration resistant prostate cancer. Eligible men will be randomized with equal probability to one of the three regimens. All patients will receive a packet of print material on diet, exercise, and psycho-social support appropriately geared for men with late stage disease at the end of the trial. The aerobic exercise arm (N=13) will receive a 3 day/week remotely-supervised exercise regimen that includes high-intensity interval training and continuous vigorous intensity aerobic exercise training. The resistance exercise arm (N=13) will receive a 3 day/week remotely-supervised resistance exercise regimen incorporating different volumes and loads. Men in the control arm (N=13) will be asked to continue their typical exercise practices for 12 weeks. Subjects will be asked to complete questionnaires, physical function and strength tests, body measurements, and collection of blood specimen at baseline and 12 weeks.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental: Arm 1 (Aerobic Exercise)

Arm 1 will engage in a periodized program consisting of 3 aerobic exercise sessions per week comprised of two high-intensity interval training workouts and 1 continuous vigorous intensity workout. A physical assessment, physical function and strengths tests, and questionnaires will be completed at baseline and 3 months.

Group Type: EXPERIMENTAL

Experimental: Arm 1 (Aerobic Exercise)

Intervention Type: BEHAVIORAL

This periodized program consists of 3 aerobic exercise sessions per week comprised of two high-intensity interval training workouts and 1 continuous vigorous intensity workout.

Experimental: Arm 2 (Resist. Exercise)

Arm 2 will engage in a periodized program consisting of 3 resistance exercise sessions per week comprised of various loads and volumes. A physical assessment, physical function and strengths tests, and questionnaires will be completed at baseline and 3 months.

Group Type: EXPERIMENTAL

Experimental: Arm 2 (Resist. Exercise)

Intervention Type: BEHAVIORAL

This periodized program consisting of 3 resistance exercise sessions per week comprised of high load/low volume, light load/high volume, and moderate load/moderate volume.

No Intervention: Arm 3 (Control)

Arm 3 will follow their usual exercise and lifestyle routine. A physical assessment, physical function and strengths tests, and questionnaires will be completed at baseline and 3 months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Experimental: Arm 1 (Aerobic Exercise)

This periodized program consists of 3 aerobic exercise sessions per week comprised of two high-intensity interval training workouts and 1 continuous vigorous intensity workout.

Intervention Type: BEHAVIORAL

Experimental: Arm 2 (Resist. Exercise)

This periodized program consisting of 3 resistance exercise sessions per week comprised of high load/low volume, light load/high volume, and moderate load/moderate volume.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Histologically documented adenocarcinoma of the prostate with systemic bone or node metastatic disease despite castrate levels of testosterone (<50 ng/dL) due to orchiectomy or luteinising hormone-releasing hormone (LHRH) agonist. Castrate levels of testosterone must be maintained while on study. Men can be enrolled prior to starting abiraterone and/or enzalutamide OR already be receiving treatment with abiraterone and/or enzalutamide.
• On androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy. All patients will be required to be on ADT throughout the study.
• ≥4 weeks since any major surgery and fully recovered
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Required Initial Laboratory Values:

• Platelet count ≥ 100,000/microliter (uL)
• Hepatic and renal dysfunction that would preclude participation in an exercise program, in the opinion of the treating physician
• Serum testosterone ≤ 50 ng/dL
• Medical clearance to undergo steep ramp test and completion of steep ramp test
• Physician consent to participate in vigorous aerobic or resistance exercise training
• Age ≥18 years

Exclusion Criteria

• Men with small cell neuroendocrine tumors or features of small cell disease
• Chemotherapy criteria: Metastatic castrate-resistant prostate cancer (CRPC) pre-chemo (metastatic castration-resistant adenocarcinoma prostate cancer, pre-CRPC chemotherapy), which is given for hormone-sensitive prostate cancer, is allowed. Metastatic CRPC post- chemo (metastatic castrate-resistant adenocarcinoma prostate cancer, post-CRPC chemotherapy) is allowed with the treating physician's (oncologist) discretion/approval.
• Poorly controlled hypertension
• Any contraindications to vigorous exercise, including, but not limited to: brain metastases, current congestive heart failure, serious or non-healing wound, and no serious cardiovascular events within 12 months
• Experiences shortness of breath, chest discomfort, or palpitations when performing activities of daily living (can participate with cardiologist clearance)
• Has difficulty climbing a flight of stairs due to physical impairment
• Has been recommended by a doctor to only medically supervised activity
• Has chest pain brought on by physical activity (can participate with cardiologist clearance)
• Has developed chest pain in the past month (can participate with cardiologist clearance)
• Serious or non-healing wound, ulcer, or bone fracture
• Spinal cord compromise or instrumentation due to metastatic disease. Radiation therapy for metastatic disease is allowed.
• Serious or non-healing wound, ulcer, or bone fracture.
• Spinal cord compromise or instrumentation due to metastatic disease. Radiation therapy for metastatic disease is allowed.
• Any peripheral neuropathy ≥grade 3
• Moderate-to-severe bone pain (i.e., National Cancer Institute's Common Terminology Criteria for Adverse Events grade 2-3 bone pain).
• Men participating in vigorous aerobic exercise for 75 minutes or more per week and/or resistance exercise three or more days per week
• Men who do not complete the baseline lifestyle and quality-of-life questionnaires

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacey A Kenfield, ScD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

R21CA184605

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2017-01928

Identifier Type: REGISTRY

Identifier Source: secondary_id

155510

Identifier Type: -

Identifier Source: org_study_id