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

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ClinicalTrials.gov Identifier: NCT02613273
Recruitment Status : Recruiting
First Posted : November 24, 2015
Last Update Posted : October 9, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This Phase II, open-label, three-arm randomized controlled trial (RCT) will investigate the effects of 12 weeks of supervised aerobic exercise vs. 12 weeks of supervised 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Experimental: Arm 1 (Aerobic Exercise) Behavioral: Experimental: Arm 2 (Resist. Exercise) Not Applicable

Detailed Description:
This is a PI-initiated, randomized clinical trial of 12 weeks of supervised aerobic exercise vs. 12 weeks of supervised resistance exercise vs. usual care among 60 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=20) will receive a 3 day/week supervised exercise regimen that includes high-intensity interval training and continuous vigorous intensity aerobic exercise training. The resistance exercise arm (N=20) will receive a 3 day/week resistance exercise regimen incorporating different volumes and loads. Men in the control arm (N=20) 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: CHAMP: A Randomized Controlled Trial of High-intensity Aerobic and Resistance Exercise for Metastatic Prostate Cancer
Actual Study Start Date : July 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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, questionnaires and diet diaries will be completed at baseline and 3 months.
Behavioral: 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.

Experimental: 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, questionnaires and diet diaries will be completed at baseline and 3 months.
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.

No Intervention: No Intervention: Arm 3 (Control)
Arm 3 will follow their usual exercise and lifestyle routine. A physical assessment, physical function and strengths tests, questionnaires and diet diaries will be completed at baseline and 3 months.



Primary Outcome Measures :
  1. Safety - Adverse events [ Time Frame: 3 months ]
    We will assess adverse events at each exercise sessions and every 2 weeks in each group.

  2. Safety - Bone pain VAS [ Time Frame: 3 months ]
    We will assess bone pain VAS recorded at each exercise session.

  3. Exercise tolerance [ Time Frame: 3 months ]
    Tolerance will be measured using a Likert scale at each exercise session.

  4. Feasibility [ Time Frame: 3 months ]
    Proportion who complete 70% or more of all sessions will be recorded.


Secondary Outcome Measures :
  1. Pain [ Time Frame: 3 months ]
    Subjects will complete the BPI-SF at baseline and 3 months.

  2. Pain medication [ Time Frame: 3 months ]
    WHO analgesic scale will be used to record pain medication.

  3. general quality of life [ Time Frame: 3 months ]
    Subjects will complete the EORTC QLQ-C30 at baseline and 3 months.

  4. prostate cancer-specific quality of life [ Time Frame: 3 months ]
    Subjects will complete the EPIC-26 at baseline and 3 months.

  5. fatigue [ Time Frame: 3 months ]
    Subjects will complete the FACIT-Fatigue at baseline and 3 months.

  6. general anxiety [ Time Frame: 3 months ]
    Subjects will complete the State Trait Anxiety Inventory to assess general anxiety at baseline and 3 months.

  7. general depression [ Time Frame: 3 months ]
    Subjects will complete the Center for Epidemiological Studies Depression Scale at baseline and 3 months.

  8. objective physical function [ Time Frame: 3 months ]
    Subjects will be assessed using the steep ramp, repeated chair rise, stair climb, and 400m walk.

  9. objective strength [ Time Frame: 3 months ]
    Subjects will be assessed using 1RM tests.


Other Outcome Measures:
  1. Halabi prognostic score [ Time Frame: 3 months ]
    Subjects will be assessed using the Halabi prognostic score at baseline and 3 months.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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 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:

    • Absolute neutrophil count (ANC) ≥ 1500/uL
    • Platelet count ≥ 100,000/uL
    • Creatinine ≤ 1.5 x upper limits of normal
    • Bilirubin ≤ 1.5 x upper limits of normal
    • Aspartate aminotransferase (AST) ≤ 1.5 x upper limits of normal
    • PSA ≥ 0.2 ng/ml
    • 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

Exclusion Criteria:

  • Previously identified small cell neuroendocrine tumors or pure small cell carcinoma of the prostate, based on a prior biopsy of the prostate.
  • Brain metastases (brain imaging is not required)
  • Any prior chemotherapy for castrate-resistant disease
  • Poorly controlled hypertension.
  • Current congestive heart failure (New York Heart Association Class II, III or IV)
  • Recent serious cardiovascular events (within 12 months) including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI).
  • Medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the physician, would make this protocol unreasonably hazardous for the patient
  • 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.
  • Peripheral neuropathy ≥grade 3.
  • Men participating in vigorous aerobic exercise for 75 minutes or more per week and/or resistance exercise three or more days per week
  • Experiences shortness of breath, chest discomfort, or palpitations when performing activities of daily living
  • Has difficulty climbing a flight of stairs or walking eight blocks due to physical impairment
  • Has been recommended by a doctor to only medically supervised activity
  • Has chest pain brought on by physical activity
  • Has developed chest pain in the past month
  • Moderate-to-severe bone pain (i.e., National Cancer Institute's Common Terminology Criteria for Adverse Events grade 2-3 bone pain).
  • Men who do not complete the baseline lifestyle and quality-of-life questionnaires

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613273


Contacts
Contact: Paula Dutton 415-885-7871 Paula.Dutton@ucsf.edu
Contact: Imelda Tenggara 415-353-7348 Imelda.Tenggara@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Paula Dutton    415-885-7871    paula.dutton@ucsf.edu   
Principal Investigator: Stacey A Kenfield, ScD         
Principal Investigator: Charles J Ryan, MD         
Sub-Investigator: June M Chan, ScD         
Sub-Investigator: Erin L Van Blarigan, ScD         
Sub-Investigator: Anthony C Luke, MD         
Sub-Investigator: Peter R Carroll, MD         
Sub-Investigator: Li Zhang, PhD         
Sub-Investigator: Robert Newton, PhD         
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stacey A Kenfield, ScD University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02613273     History of Changes
Other Study ID Numbers: 15-17132
R21CA184605 ( U.S. NIH Grant/Contract )
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases