EX-HEART TRIAL: Exercise for heart health in prostate cancer

Not Applicable

Active, not recruiting

• Conditions: Prostate cancer; Cardiovascular disease; Cardiovascular - Normal development and function of the cardiovascular system; Cancer - Prostate

• Registration Number: ACTRN12618001155280
• Lead Sponsor: Australian Catholic University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-13
• Last Update Posted: 13 June 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 41

Inclusion Criteria

The inclusion criteria for the prostate cancer group are:
•Histologically confirmed prostate cancer
•40 years and older
•Currently receiving or scheduled to receive androgen deprivation therapy (<1 month of initiating therapy) with or without upfront chemotherapy

Additionally, 10 aged-matched control participants will be recruited to assess the trajectory of change in cardiovascular function. Men will be included if they are male and have not been diagnosed with cancer.

Exclusion Criteria

The exclusion criteria for the prostate cancer group and age-matched control are:
•Unstable heart condition determined by study doctor and/or general practitioner
•Previously received ADT or chemotherapy for the treatment of a previous cancer
•Acute illness or any musculoskeletal, cardiovascular or neurological disorder that
could inhibit exercise or put participants at risk during exercise testing
•A contraindication to cardiac magnetic resonance imaging is a metallic implant or cardiac pacemaker

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in left ventricular mass to volume ratio will be assessed with cardiac magnetic resonance imaging (CMR). The proportion of participants with a > 10% change in left ventricular mass to volume ratio will be assessed with CMR and Circle Cardiovascular Imaging software. Cardiac volumes (end-diastolic and end-systolic volume) will be calculated using the contouring technique in the end-diastole and end-systole of each cardiac cycle.<br>Update<br>[(1) Baseline - currently receiving or scheduled to receive androgen deprivation therapy (<1 month of initiating therapy)<br>(2) 3-month follow up - 3-months since first administration of androgen deprivation therapy. <br>(3) 12-months - 12-months since first administration of androgen deprivation therapy (primary endpoint)]