Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer

NCT03672396 | Completed Results DMC

• 1 other identifier: LCCC1613
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Castration-resistant Prostate Cancer; Androgen Deprivation Therapy

Keywords

exercise; hormone therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Complete the Pre/Post Exercise Intervention Testing.

  To estimate the feasibility of a 12 week, home-based exercise intervention in metastatic castrate resistant prostate cancer (mCPRC) patients undergoing androgen deprivation therapy by reporting the percentage of patients who complete the pre/post testing following the intervention. This was calculated as the number of subjects who completed the trial compared to the total number who completed baseline testing.

  12 weeks after baseline testing

Secondary Outcomes (19)

• Adherence to the Intervention

  12 weeks after baseline testing

• Physical Function: 6m Walk

  12 weeks after baseline testing

• Physical Function: Timed Up and Go

  12 weeks after baseline testing

• Physical Function: Stair Climb

  12 weeks after baseline testing

• Physical Function: 400m Walk

  12 weeks after baseline testing

Study Arms (1)

Home-based Exercise

EXPERIMENTAL

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.

Behavioral: Home-based exercise

Interventions

Home-based exercise BEHAVIORAL

The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.

Home-based Exercise

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Wake Forest University Health Sciences: collaborator

Study Sites (2)

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Comprehensive Cancer Center, Wake Forest Baptist Health

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Erik Hanson, PhD
• Organization: University of North Carolina at Chapel Hill

edhanson@email.unc.edu

19199620816

Study Officials

• Erik D Hanson, PhD

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm study with \~30 men being recruited and 20-25 who complete all aspects of the study.

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 14, 2018
• Study Start: April 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 20, 2021
• Results First Posted: January 12, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)