Clinical trial NCT03776045: PROState Cancer Patients Initiating Hormone Therapy: Effect of Exercise on CARDIOvascular Health (PROSCARDIO)
Official title: Effects of Exercise in Prostate Cancer Patients Initiating Androgen Deprivation Therapy: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Androgen deprivation therapy
Exercise
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Norfolk and Norwich University Hospitals NHS Foundation Trust
First posted: 2018-12-14
Enrollment: 50
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After baseline measures were collected, participants were randomly allocated (1:1) to standard care or standard care plus exercise using a randomisation sequence created by an independent researcher (nQuery, Statistical Solutions, USA). Treatment allocation was concealed from the research team until after baseline measurements were collected.
Primary purpose: PREVENTION

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-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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Whole body fat mass (kg)
timeFrame: Adjusted mean difference between groups at 3-month endpoint
Secondary outcomes:
measure: Whole body fat mass (kg)
timeFrame: Adjusted mean difference between groups at 6-month endpoint
measure: Whole body fat-free mass (kg)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Anthropometric measurements (cm)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Peak oxygen consumption (VO2peak, ml/kg/min)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Ventilatory anaerobic threshold (ml/kg/min)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Ventilatory equivalents for O2 (V̇E/V̇O2) and CO2 (V̇E/V̇CO2)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Oxygen pulse (ml/beat)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Oxygen uptake efficiency slope (OUES)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Concentration of cholesterol (mmol/L)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Concentration of triglycerides (mmol/L)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Concentration of testosterone (nmol/L)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Concentration of sex hormone binding globulin (nmol/L)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: QRISK®2-2017 score
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Gleason score
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Prostate specific antigen (ng/mL)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Skinfold thickness (mm)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Hand grip strength (kg)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: The Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire (version 4)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale (version 4)
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Godin Leisure-Time Exercise questionnaire
timeFrame: Adjusted mean difference between groups at 3-month and 6-month endpoints
measure: Number of recruited participants
timeFrame: Descriptive statistics reported during the two-year recruitment period
measure: Number of adverse events
timeFrame: Descriptive statistics reported during the 3-month intervention period
measure: Attrition rate
timeFrame: Descriptive statistics reported during the 3-month intervention period.
measure: Number of patients who were lost to follow-up
timeFrame: Descriptive statistics reported at 3-month and 6-month endpoints
measure: Average number of exercise sessions completed
timeFrame: Descriptive statistics reported during the 3-month intervention period
Other outcomes:
Locations:
Study officials:
affiliation: Northumbria University
name: John Saxton, Saxton
role: STUDY_DIRECTOR
affiliation: Norfolk and Norwich University Hospitals NHS Foundation Trust
name: Wilphard Ndjavera, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galvao DA, Taaffe DR, Spry N, Joseph D, Newton RU. Acute versus chronic exposure to androgen suppression for prostate cancer: impact on the exercise response. J Urol. 2011 Oct;186(4):1291-7. doi: 10.1016/j.juro.2011.05.055. Epub 2011 Aug 17.
citation: Savastano S, Belfiore A, Di Somma C, Mauriello C, Rossi A, Pizza G, De Rosa A, Prestieri G, Angrisani L, Colao A. Validity of bioelectrical impedance analysis to estimate body composition changes after bariatric surgery in premenopausal morbidly women. Obes Surg. 2010 Mar;20(3):332-9. doi: 10.1007/s11695-009-0006-5. Epub 2009 Oct 28.