Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Androgen Deprivation Therapy; Castration-resistant Prostate Cancer

Treatments: Behavioral: Home-based exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03672396

LCCC1613

Details and patient eligibility

About

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.

Full 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)).

Enrollment: 22 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

22 participants in 1 patient group

Home-based Exercise

Experimental group

Description:

The sole intervention group will complete a combination of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour.

Treatment:

Behavioral: Home-based exercise