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The ExPeCT (Examining Exercise, Prostate Cancer and Circulating Tumour Cells) trial: study protocol for a randomised controlled trial.
Sheill, Gráinne Brady, Lauren Guinan, Emer Hayes, Brian Casey, Orla Greene, John Vlajnic, Tatjana Cahill, Fidelma Van Hemelrijck, Mieke Peat, Nicola
Sheill, Gráinne
Brady, Lauren
Guinan, Emer
Hayes, Brian
Casey, Orla
Greene, John
Vlajnic, Tatjana
Cahill, Fidelma
Van Hemelrijck, Mieke
Peat, Nicola
Author
Sheill, Gráinne
Brady, Lauren
Guinan, Emer
Hayes, Brian
Casey, Orla
Greene, John
Vlajnic, Tatjana
Cahill, Fidelma
Van Hemelrijck, Mieke
Peat, Nicola
Rudman, Sarah
Hussey, Juliette
Cunningham, Moya
Grogan, Liam
Lynch, Thomas
Manecksha, Rustom P
McCaffrey, John
Mucci, Lorelei
Sheils, Orla
O'Leary, John
O'Donnell, Dearbhaile M
McDermott, Ray
Finn, Stephen
Brady, Lauren
Guinan, Emer
Hayes, Brian
Casey, Orla
Greene, John
Vlajnic, Tatjana
Cahill, Fidelma
Van Hemelrijck, Mieke
Peat, Nicola
Rudman, Sarah
Hussey, Juliette
Cunningham, Moya
Grogan, Liam
Lynch, Thomas
Manecksha, Rustom P
McCaffrey, John
Mucci, Lorelei
Sheils, Orla
O'Leary, John
O'Donnell, Dearbhaile M
McDermott, Ray
Finn, Stephen
Advisors
Editors
Other Contributors
Departments
Date
2017-10-04
Date Submitted
Keywords
PROSTATE CANCER
EXERCISE
EXERCISE
Other Subjects
Subject Mesh
Adenocarcinoma
Clinical Protocols
Exercise Therapy
Health Status
Humans
Inflammation Mediators
Ireland
London
Male
Neoplastic Cells, Circulating
Obesity
Prospective Studies
Prostatic Neoplasms
Quality of Life
Research Design
Surveys and Questionnaires
Time Factors
Treatment Outcome
Tumor Escape
Clinical Protocols
Exercise Therapy
Health Status
Humans
Inflammation Mediators
Ireland
London
Male
Neoplastic Cells, Circulating
Obesity
Prospective Studies
Prostatic Neoplasms
Quality of Life
Research Design
Surveys and Questionnaires
Time Factors
Treatment Outcome
Tumor Escape
Planned Date
Start Date
Collaborators
Principal Investigators
Files
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Main Article
Adobe PDF, 1.32 MB
Alternative Titles
Publisher
Abstract
Prostate cancer (PrCa) is the second most common cancer in Ireland. Many men present with locally advanced or metastatic cancer for whom curative surgery is inappropriate. Advanced cancer patients are encouraged to remain physically active and therefore there is a need to investigate how patients with metastatic disease tolerate physical activity programmes. Physical activity reduces levels of systemic inflammatory mediators and so an aerobic exercise intervention may represent an accessible and cost-effective means of ameliorating the pro-inflammatory effects of obesity and subsequently decrease poor cancer-specific outcomes in this patient population. This study will assess the feasibility and safety of introducing a structured aerobic exercise intervention to an advanced cancer population. This study will also examine if the evasion of immune editing by circulating tumour cells (CTCs) is an exercise-modifiable mechanism in obese men with prostate cancer.
This international multicentre prospective study will recruit men with metastatic prostate cancer. Participants will be recruited from centres in Dublin (Ireland) and London (UK). Participants will be divided into exposed and non-exposed groups based on body mass index (BMI) ≥ 25 kg/m2 and randomised to intervention and control groups. The exercise group will undertake a regular supervised aerobic exercise programme, whereas the control group will not. Exercise intensity will be prescribed based on a target heart rate monitored by a polar heart rate monitor. Blood samples will be taken at recruitment and at 3 and 6 months to examine the primary endpoint of platelet cloaking of CTCs. Participants will complete a detailed questionnaire to assess quality of life (QoL) and other parameters at each visit.
The overall aim of the ExPeCT trial is to examine the relationship between PrCa, exercise, obesity, and systemic inflammation, and to improve the overall QoL in men with advanced disease. Results will inform future work in this area examining biological markers of prognosis in advanced prostate cancer.
Clinicaltrials.gov NLM identifier: NCT02453139 . Registered on 12 May 2015. This document contains excerpts from the ExPeCT trial protocol Version 1.5, 28 July 2016.
This international multicentre prospective study will recruit men with metastatic prostate cancer. Participants will be recruited from centres in Dublin (Ireland) and London (UK). Participants will be divided into exposed and non-exposed groups based on body mass index (BMI) ≥ 25 kg/m2 and randomised to intervention and control groups. The exercise group will undertake a regular supervised aerobic exercise programme, whereas the control group will not. Exercise intensity will be prescribed based on a target heart rate monitored by a polar heart rate monitor. Blood samples will be taken at recruitment and at 3 and 6 months to examine the primary endpoint of platelet cloaking of CTCs. Participants will complete a detailed questionnaire to assess quality of life (QoL) and other parameters at each visit.
The overall aim of the ExPeCT trial is to examine the relationship between PrCa, exercise, obesity, and systemic inflammation, and to improve the overall QoL in men with advanced disease. Results will inform future work in this area examining biological markers of prognosis in advanced prostate cancer.
Clinicaltrials.gov NLM identifier: NCT02453139 . Registered on 12 May 2015. This document contains excerpts from the ExPeCT trial protocol Version 1.5, 28 July 2016.
Language
en
ISSN
1745-6215
eISSN
ISBN
DOI
10.1186/s13063-017-2201-3
PMID
28978344