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

Metastatic Castration Resistant Prostate Cancer (mCRPC) Clinical Trial

Official title:

Randomized, Controlled Study of an Exercise Intervention Program for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Either Abiraterone or Enzalutamide

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02130947
• Other study ID #: LCCC 1339
• Secondary ID: 14-0177
• Status: Withdrawn
• Phase: N/A
• First received: May 1, 2014
• Last updated: February 10, 2016
• Start date: April 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Metastatic Castration Resistant Prostate Cancer (mCRPC)
• Prostatic Neoplasms

Intervention

Behavioral:
• Exercise

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks	No

External Links

•   Lineberger Comprehensive Cancer Center website
•   National Cancer Institute (NCI) website