Condition category
Cancer
Date applied
22/09/2017
Date assigned
13/10/2017
Last edited
12/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Dr Lucy Hackshaw-McGeagh

ORCID ID

Contact details

NIHR Bristol Biomedical Research Centre
Level 3
University Hospitals Bristol Research & Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2839

Study information

Scientific title

Feasibility randomised controlled trial to explore implications of a physical activity intervention on Cardiopulmonary Exercise Testing (CPET) and other outcomes in men with localised prostate cancer prior to radical prostatectomy

Acronym

Study hypothesis

The aim of this study is to explore the impact of moderate-vigorous physical activity on anaerobic threshold, in men with localised prostate cancer, as measured by Cardiopulmonary Exercixe Testing (CPET).

Ethics approval

Not provided at time of registration.

Study design

Two arm randomised control feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Localised prostate cancer

Intervention

Participants are randomised (1:1) into a physical activity intervention arm or the control arm. This is carried out using a computer generated programme by a member of university staff unrelated to the research study.

Men in the intervention arm are asked to carry out moderate-vigorous physical activity. Participant interventions are asked to walk at a brisk pace for 30 minutes, on at least 5 days a week, on top of normal physical activity, with the additional aim to walk 10,000 steps every day. Participants are provided with a wrist worn activity monitor which provide real time feedback and motivational reminders. The participants are instructed to do this by the research nurse at their research appointment. They are asked to carry out the intervention from randomisation until their surgery which are approximately 4-6 weeks in duration.

Participants in the control arm are asked to carry on with normal physical activity. Baseline takes place at randomisation, follow up is done just prior to surgery approx. 4-6 post randomisation.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

CPET quantitative measures for fitness pre- and -post exercise intervention are measured using peak oxygen uptake (VO2) and surrogate measures of lung efficiency of ventillatory equivalents for CO2 and O2, as well as the AT
Quantitative measures for fitness pre- and -post exercise intervention will include peak oxygen uptake (VO2) and surrogate measures of lung efficiency of ventilatory equivalents for CO2 and O2 measured using Cardiopulmonary exercise testing (CPET) monitoring at baseline and prior to surgery (approx. 4-6 weeks post randomisation / baseline).

Secondary outcome measures

1. Effects on markers of proliferation and metabolic pathways, including p AMPK/AMPK, p IGF-I receptor/ IGF-I receptor, FASN, PTEN, IGFBP-2, Ki67 and pACCA/ ACCA are measured using blood and prostate tissue at baseline and prior to/during surgery (approx. 4-6 weeks post randomisation/baseline)
2. Randomisation rates are measured using the proportion of eligible men approached who agree to be randomised baseline
3. Retention rates measured using the number of participants successfully followed-up, as a proportion of those who were randomised just prior to surgery (approx. 4-6 weeks post randomisation/baseline)
4. Change in prostate specific antigen (PSA) level collected via blood sample at baseline and prior to surgery (approx. 4-6 weeks post randomisation/baseline)
5. Change in insulin-like growth factor (IGF-I) level collected via blood sample at baseline and prior to surgery (approx. 4-6 weeks post randomisation / baseline)
6. Change in Quality of life collected via validated questionnaire (The Functional Assessment of Cancer Therapy – Prostate subscale (FACT-P) and Functional Assessment of Chronic Illness Therapy – Fatigue subscale (FACIT-F) questionnaires) at baseline and prior to surgery (approx. 4-6 weeks post randomisation/baseline)

Overall trial start date

12/06/2017

Overall trial end date

30/04/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Localised prostate cancer
2. Be due to undergo radical prostatectomy
3. Be due to receive treatment at Southmead Hospital, North Bristol NHS Trust
4. Capacity to consent for themselves as judged by a member of the research team with appropriate training and experience
5. Be aged 18 or over, there is no upper age limit
6. Have sufficient understanding of the English language, including being able to read and speak English at a basic level
7. Be physically able to undergo the brisk walking intervention and CPET static bike assessment

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

20

Participant exclusion criteria

1. Inability to give informed consent or unavailability for follow-up
2. Being identified as unsuitable to participate following guidance of their clinician
3. The use of a mobility aid other than a walking stick that would prevent them from carrying out the brisk walking intervention
4. Any co-morbidities or other reason for not being able to participate in any aspect of the intervention
5. Participants already achieving physical activity levels over the physical activity intervention level

Recruitment start date

01/11/2017

Recruitment end date

21/02/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southmead Hospital
Southmead Road Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Senate House
Tyndall Avenue
Bristol
BS8 2PS
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Bristol Biomedical Research Centre (Nutrition Theme)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal and via national and international conferences at approximately 30/04/2019.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/04/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes