PROState Cancer Patients Initiating Hormone Therapy: Effect of Exercise on CARDIOvascular Health (PROSCARDIO)

University of East Anglia

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: Standard care plus exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03776045

PROSCARDIO1992

Details and patient eligibility

About

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-month exercise intervention, while the other half did not perform any supervised exercise. It was anticipated that exercise would have a positive effect on body composition, cardiorespiratory fitness and quality of life.

Full 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 mass and reduced skeletal muscle mass, cardiorespiratory fitness and metabolic health. Ultimately, these negative changes induced by ADT contribute to reduced health-related quality of life (HRQoL). This study evaluates whether 3-months of exercise can mitigate treatment toxicity in prostate cancer patients initiating ADT.

In a parallel groups, prospective, randomised controlled design, participants were randomly allocated to a standard care control group or standard care plus exercise group. The exercise group completed 3-months of combined aerobic and resistance training. The standard care group did not receive any supervised exercise or specific physical activity recommendations. Outcomes were assessed at baseline, 3-month (post-intervention), and 6-month (follow-up) endpoints.

Enrollment: 50 patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Standard care

No Intervention group

Description:

This group did not receive any supervised exercise or were not given any specific exercise recommendations during the trial period. However, patients in this group were offered the exercise intervention after completing the study.

Standard care plus exercise

Experimental group

Description:

This group received standard care in addition to a 3-month exercise intervention upon initiating androgen deprivation therapy.

Treatment:

Other: Standard care plus exercise