Status:
COMPLETED
PROState Cancer Patients Initiating Hormone Therapy: Effect of Exercise on CARDIOvascular Health (PROSCARDIO)
Lead Sponsor:
University of East Anglia
Collaborating Sponsors:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Conditions:
Prostate Cancer
Eligibility:
MALE
50-80 years
Phase:
NA
Brief Summary
This study evaluates whether exercise can reduce treatment-related adverse effects in prostate cancer patients initiating androgen deprivation therapy. Half of recruited participants completed a 3-mon...
Detailed Description
Androgen deprivation therapy (ADT) is routinely used as first-line treatment for locally advanced and metastatic prostate cancer. However, it is associated with many side effects such as increased fat...
Eligibility Criteria
Inclusion
- Male
- Aged 50 to 80 years
- Histologically confirmed stage I-IV prostate cancer
- Scheduled for treatment with a luteinizing hormone-releasing hormone (LHRH) agonist either alone or combined with radiotherapy
- Anticipated to remain on androgen deprivation therapy (ADT) for at least the next 6 months
- Willing and able to give written informed consent.
- Understand written and verbal instructions in English
- World Health Organisation (WHO) performance status 0 to 1
Exclusion
- Previously treated with ADT
- Diagnosed or suspected metastatic bone disease
- Absolute contraindications to exercise testing and training as defined by the American College of Sports Medicine (ACSM, 2010)
- Prior myocardial infarction or heart failure
- Chronic obstructive pulmonary disease (COPD)
- Poorly controlled hypertension (≥ 200/110 mmHg)
- Uncontrolled supraventricular tachycardia (≥ 100 bpm)
- Pre-existing severe musculoskeletal, neurological or psychiatric condition that may affect their ability to complete the testing battery or exercise training, as determined by the patient's physician
- Involvement in any other clinical trial or exercise trial
Key Trial Info
Start Date :
August 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03776045
Start Date
August 12 2013
End Date
February 3 2016
Last Update
December 14 2018
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