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Exercise Intervention for Pts With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide

Primary Purpose

Metastatic Castration Resistant Prostate Cancer (mCRPC)

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional supportive care trial for Metastatic Castration Resistant Prostate Cancer (mCRPC) focused on measuring Metastatic Castration Resistant Prostate Cancer, Prostate Cancer, mCRPC, Pilot Study, UNC Lineberger, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

Lineberger Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise Intervention Arm

Non-Exercise Control Arm

Arm Description

The exercise intervention will consist of a combination of aerobic (cardiovascular exercise) and strength training (emphasis of the intervention) 3 times per week for 12 weeks with each session lasting ~1.5 hours.

Participants in the Non-Exercise Control Arm will not exercise for 12 weeks.

Outcomes

Primary Outcome Measures

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)

DEXA (Dual-energy X-ray absorptiometry) scans will measure lean mass at baseline and after the 12-week intervention.

Secondary Outcome Measures

Full Information

NCT ID

NCT02130947

First Posted

May 1, 2014

Last Updated

February 10, 2016

Sponsor

UNC Lineberger Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02130947

Brief Title

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

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Withdrawn

Why Stopped

We were not able to accrue any participants.

Study Start Date

April 2014 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UNC Lineberger Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Castration Resistant Prostate Cancer (mCRPC)

Keywords

Metastatic Castration Resistant Prostate Cancer, Prostate Cancer, mCRPC, Pilot Study, UNC Lineberger, Exercise

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise Intervention Arm

Arm Type

Experimental

Arm Description

Arm Title

Non-Exercise Control Arm

Arm Type

No Intervention

Arm Description

Participants in the Non-Exercise Control Arm will not exercise for 12 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Primary Outcome Measure Information:

Title

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)

Description

DEXA (Dual-energy X-ray absorptiometry) scans will measure lean mass at baseline and after the 12-week intervention.

Time Frame

12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony C Hackney, Ph.D., D.Sc.

Organizational Affiliation

University of North Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lineberger Comprehensive Cancer Center

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Links:

URL

http://unclineberger.org/

Description

Lineberger Comprehensive Cancer Center website

URL

http://www.cancer.gov/

Description

National Cancer Institute (NCI) website

Learn more about this trial

Exercise Intervention for Pts With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide

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