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

NCT02613273 | Completed DMC

• 3 other identifiers: 155510R21CA184605NCI-2017-01928
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (5)

• Number of self-reported adverse events by arm

  Adverse events will be assessed at each weekly coach call, at clinic visits during the study, and at the 12-week study visit. They are continuously reported from informed consent until 28 days after the 12-week study visit.

  Up to 4 months

• Attendance at 70% or more of exercise sessions.

  Study feasibility will be determined by the proportion of participants who complete 70 percent or more of all sessions.

  3 months

• Adherence at 70% or more of the completed exercise sessions.

  Study feasibility will be determined by the proportion of participants who completed 70 percent or more of the exercise sessions as or more than prescribed.

  3 months

• Median sessional tolerance

  Exercise tolerance will be assessed by participant self-report of a single question at each exercise session using a 10 point Likert scale with a minimum score of 0=intolerable and a maximum score of 10=highly tolerable.

  Up to 3 months

• Study acceptability

  Proportion of participants who were satisfied or very satisfied with the intervention

  3 months

Secondary Outcomes (14)

• Change in scores on the Fatigue visual analog scale (VAS)

  3 months

• Change in scores on the Bone pain visual analog scale (VAS)

  Up to 3 months

• Number of participants reporting use of opiate pain medication

  Up to 3 months

• Change in Scores on the Brief-Pain Inventory Short Form (BPI-SF)

  Up to 3 months

• Change in objective physical function over time

  Up to 3 months

Other Outcomes (4)

• Number of participants with a change in the Halabi prognostic category over time

  3 months

• Median Progression-free Survival (PFS)

  Up to 2 years

• Median Overall Survival (OS)

  Up to 2 years

Study Arms (3)

Experimental: Arm 1 (Aerobic Exercise)

EXPERIMENTAL

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.

Behavioral: Experimental: Arm 1 (Aerobic Exercise)

Experimental: Arm 2 (Resist. Exercise)

EXPERIMENTAL

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.

Behavioral: Experimental: Arm 2 (Resist. Exercise)

No Intervention: Arm 3 (Control)

NO INTERVENTION

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.

Interventions

Experimental: Arm 1 (Aerobic Exercise) 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 1 (Aerobic Exercise)

Experimental: Arm 2 (Resist. Exercise) 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.

Experimental: Arm 2 (Resist. Exercise)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stacey A Kenfield, ScD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 24, 2015
• Study Start: July 18, 2016
• Primary Completion: March 31, 2020
• Study Completion: June 30, 2022
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)