Clinical trial NCT02130947: Exercise Intervention for Pts With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide
Official title: Randomized, Controlled Study of an Exercise Intervention Program for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Either Abiraterone or Enzalutamide
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Metastatic Castration Resistant Prostate Cancer (mCRPC)
Keywords: Metastatic Castration Resistant Prostate Cancer
Prostate Cancer
mCRPC
Pilot Study
UNC Lineberger
Exercise
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized pilot study will be conducted in men with metastatic castration resistant prostate cancer (mCRPC) within 3 months of initiating abiraterone or enzalutamide. The purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in mCRPC patients who have recently started on additional androgen suppression therapy.

Detailed description: This randomized pilot study will be conducted in men with metastatic castration resistant prostate cancer (mCRPC) within 3 months of initiating abiraterone or enzalutamide. The purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in mCRPC patients who have recently started on additional androgen suppression therapy. The investigators will also explore the effects of the exercise training on biomarkers of inflammation-hormonal status and their potential association with changes in lean mass and function.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years of age
2. Metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of \< 50 ng/dL)
3. No prior chemotherapy
4. Initiated therapy with either abiraterone plus a glucocorticoid or enzalutamide within the 3 months prior to randomization
5. Ability to engage safely in moderate exercise as determined by their treating physician
6. Not previously engaged in regular exercise training (\>1-2 d/wk for \> 30 min/d) in the past 6 months
7. Be able to speak and read English

Exclusion Criteria:

1. Any condition that causes severe pain with exertion
2. History of bone fractures
3. Active cardiovascular disease including any of the following:

   * New York Heart Association (NYHA) Grade II or greater congestive heart failure
   * History of myocardial infarction or unstable angina within 6 months prior to Day 1
   * History of stroke or transient ischemic attack within 6 months prior to Day 1
4. Acute or chronic respiratory disease
5. Acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise
6. Neurological conditions that affect balance and, or muscle strength
7. Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent

Primary outcomes:
measure: Change in lean mass between mCPRC patients undergoing a 12-week exercise intervention (intervention group) and mCPRC patients who do not undergo the exercise intervention (control group)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Anthony C Hackney, Ph.D., D.Sc.
role: PRINCIPAL_INVESTIGATOR
References: