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

NCT ID: NCT03776045

Last Updated: 2018-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-12

Study Completion Date

2016-02-03

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Keywords

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Prostate Cancer Androgen deprivation therapy Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors and data analysts were blind to treatment allocation. It was not possible to blind participants or the intervention facilitator.

Study Groups

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Standard care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Standard care plus exercise

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

Group Type EXPERIMENTAL

Standard care plus exercise

Intervention Type 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).

Interventions

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Standard care plus exercise

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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Norfolk and Norwich University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of East Anglia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Saxton, Saxton

Role: STUDY_DIRECTOR

Northumbria University

Wilphard Ndjavera, MD

Role: PRINCIPAL_INVESTIGATOR

Norfolk and Norwich University Hospitals NHS Foundation Trust

References

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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.

Reference Type BACKGROUND
PMID: 21849187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19862582 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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PROSCARDIO1992

Identifier Type: -

Identifier Source: org_study_id