Clinical trial NCT03672396: Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer
Official title: Feasibility Study of a Home-Based Exercise Intervention Program for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Castration-resistant Prostate Cancer
Androgen Deprivation Therapy
Keywords: exercise
hormone therapy
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
First posted: 2018-09-14
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm study with \~30 men being recruited and 20-25 who complete all aspects of the study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This single arm, multi-site pilot study aims to evaluate the feasibility of recruiting and adherence to a 12 week home-based exercise intervention to be conducted in men with metastatic castration resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Thirty patients will be enrolled, with the expectation that 20-25 will complete all follow-up measures.

Detailed description: The purpose of this trial is to evaluate the feasibility and adherence to a home-based 12 week exercise intervention in mCRPC patients receiving ADT. It will also examine if a home-based exercise intervention can improve muscle strength, body composition, physical function, cardiopulmonary function fatigue, and patient reported outcomes (fatigue, depression, quality of life (QoL)).

Eligibility criteria: Inclusion Criteria:

* Metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of \< 50 ng/dL) receiving ADT. This will be verified by assessing total testosterone levels within 4 weeks prior to enrollment.
* No current chemotherapy.
* Patients may be receiving additional hormonal therapy agents including but not limited to antiandrogens (e.g. bicalutamide, enzalutamide) and CYP17 inhibitors (e.g. abiraterone).
* Ability to engage safely in moderate exercise as determined by their treating physician.
* Not previously engaged in regular exercise training (\<3 or more d/wk for \> 30 min/d or \<90 mins per week total including strength training, aerobic training, or walking) in the past 6 months.
* Access to a computer or a smart phone for syncing and uploading wearable activity data.
* Be able to speak and read English.

Exclusion Criteria:

* Any condition that causes severe pain with exertion.
* History of bone fractures.
* 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.
* Acute or chronic respiratory disease that is severe enough to compromise the ability of the participant to safely engage in exercise training protocol.
* Acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise.
* Neurological conditions that affect balance and, or muscle strength.
* Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent.

Primary outcomes:
measure: Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing.
timeFrame: 12 weeks after baseline testing
Secondary outcomes:
measure: Adherence to the Intervention
timeFrame: 12 weeks after baseline testing
measure: Physical Function: 6m Walk
timeFrame: 12 weeks after baseline testing
measure: Physical Function: Timed Up and Go
timeFrame: 12 weeks after baseline testing
measure: Physical Function: Stair Climb
timeFrame: 12 weeks after baseline testing
measure: Physical Function: 400m Walk
timeFrame: 12 weeks after baseline testing
measure: Patient Reported Outcomes: Fatigue
timeFrame: 12 weeks after baseline testing
measure: Patient Reported Outcomes: Quality of Life
timeFrame: 12 weeks after baseline testing
measure: Patient Reported Outcomes: Depression
timeFrame: 12 weeks after baseline testing
measure: Patient Reported Outcomes: Anxiety
timeFrame: 12 weeks after baseline testing
measure: Muscle Size (Cross-sectional Area)
timeFrame: 12 weeks after baseline testing
measure: Muscle Quality
timeFrame: 12 weeks after baseline testing
measure: Chest Press Maximal Strength
timeFrame: 12 weeks after baseline testing
measure: Chest Press Muscle Endurance
timeFrame: 12 weeks after baseline testing
measure: Leg Press Maximal Strength
timeFrame: 12 weeks after baseline testing
measure: Leg Press Muscle Endurance
timeFrame: 12 weeks after baseline testing
measure: Cardiopulmonary Function
timeFrame: 12 weeks after baseline testing
measure: Lean Mass
timeFrame: 12 weeks after baseline testing
measure: Fat Mass
timeFrame: 12 weeks after baseline testing
measure: Percent Body Fat
timeFrame: 12 weeks after baseline testing
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center, Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Erik D Hanson, PhD
role: PRINCIPAL_INVESTIGATOR
References: