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

NCT03776045 | Completed

• 1 other identifier: PROSCARDIO1992
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Androgen deprivation therapy; Exercise

Outcome Measures

Primary Outcomes (1)

• Whole body fat mass (kg)

  Whole body fat mass was measured with bioelectrical impedance analysis (BIA) and concurrent bioelectrical impedance vector analysis (BIVA) with a single-frequency, phase-sensitive 50 kilohertz bioelectrical impedance analyzer (BIA-101, RJL/Akern Systems, Florence, Italy). This was chosen as the primary outcome because adiposity has shown a high propensity to increase during the initial phases of androgen deprivation therapy, more so than other measures (Galvao et al. 2011), which highlights the importance of targeting body fat at this stage of treatment.

  Adjusted mean difference between groups at 3-month endpoint

Secondary Outcomes (25)

• Whole body fat mass (kg)

  Adjusted mean difference between groups at 6-month endpoint

• Whole body fat-free mass (kg)

  Adjusted mean difference between groups at 3-month and 6-month endpoints

• Anthropometric measurements (cm)

  Adjusted mean difference between groups at 3-month and 6-month endpoints

• Peak oxygen consumption (VO2peak, ml/kg/min)

  Adjusted mean difference between groups at 3-month and 6-month endpoints

• Ventilatory anaerobic threshold (ml/kg/min)

  Adjusted mean difference between groups at 3-month and 6-month endpoints

Study Arms (2)

Standard care

NO INTERVENTION

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

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

Other: Standard care plus exercise

Interventions

Standard care plus exercise OTHER

The exercise was supervised by exercise science staff in the exercise science facilities at the University of East Anglia, UK. Participants competed two weekly sessions for 12 weeks upon initiating ADT. Each session lasted \~60 min and included aerobic interval exercise on a cycle ergometer (Monark 824E; Varberg, Sweden) followed by resistance training. In addition to the supervised exercise sessions, patients were advised on how to increase their habitual physical activity levels and were encouraged to engage in 30 minutes of self-directed exercise on three days each week (e.g. brisk walking, cycling, home-based resistance training).

Standard care plus exercise

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of East Anglia: lead
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator

Related Publications (2)

• 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.

  PMID: 21849187 BACKGROUND

• 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.

  PMID: 19862582 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity

Interventions

Standard of Care; Exercise

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• John Saxton, Saxton

  Northumbria University

  STUDY DIRECTOR

• Wilphard Ndjavera, MD

  Norfolk and Norwich University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts were blind to treatment allocation. It was not possible to blind participants or the intervention facilitator.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 14, 2018
• Study Start: August 12, 2013
• Primary Completion: February 3, 2016
• Study Completion: February 3, 2016
• Last Updated: December 14, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share