Prostate cancer-Exercise and Metformin Trial (Pre-EMpT): study protocol for a feasibility factorial randomized controlled trial in men with localised or locally advanced prostate cancer.

Active surveillance Feasibility randomised controlled trial Localised Locally advanced Metformin Physical activity Prostate cancer Prostatectomy Radiotherapy

Journal

Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536

Informations de publication

Date de publication:
12 Aug 2022
Historique:
received: 08 12 2021
accepted: 27 07 2022
entrez: 12 8 2022
pubmed: 13 8 2022
medline: 13 8 2022
Statut: epublish

Résumé

Evidence from observational studies have shown that moderate intensity physical activity can reduce risk of progression and cancer-specific mortality in participants with prostate cancer. Epidemiological studies have also shown participants taking metformin to have a reduced risk of prostate cancer. However, data from randomised controlled trials supporting the use of these interventions are limited. The Prostate cancer-Exercise and Metformin Trial examines that feasibility of randomising participants diagnosed with localised or locally advanced prostate cancer to interventions that modify physical activity and blood glucose levels. The primary outcomes are randomisation rates and adherence to the interventions over 6 months. The secondary outcomes include intervention tolerability and retention rates, measures of insulin-like growth factor I, prostate-specific antigen, physical activity, symptom-reporting, and quality of life. Participants are randomised in a 2 × 2 factorial design to both a physical activity (brisk walking or control) and a pharmacological (metformin or control) intervention. Participants perform the interventions for 6 months with final measures collected at 12 months follow-up. Our trial will determine whether participants diagnosed with localised or locally advanced prostate cancer, who are scheduled for radical treatments or being monitored for signs of cancer progression, can be randomised to a 6 months physical activity and metformin intervention. The findings from our trial will inform a larger trial powered to examine the clinical benefits of these interventions. Prostate Cancer Exercise and Metformin Trial (Pre-EMpT) is registered on the ISRCTN registry, reference number ISRCTN13543667 . Date of registration 2nd August 2018-retrospectively registered. First participant was recruited on 11th September 2018.

Sections du résumé

BACKGROUND BACKGROUND
Evidence from observational studies have shown that moderate intensity physical activity can reduce risk of progression and cancer-specific mortality in participants with prostate cancer. Epidemiological studies have also shown participants taking metformin to have a reduced risk of prostate cancer. However, data from randomised controlled trials supporting the use of these interventions are limited. The Prostate cancer-Exercise and Metformin Trial examines that feasibility of randomising participants diagnosed with localised or locally advanced prostate cancer to interventions that modify physical activity and blood glucose levels. The primary outcomes are randomisation rates and adherence to the interventions over 6 months. The secondary outcomes include intervention tolerability and retention rates, measures of insulin-like growth factor I, prostate-specific antigen, physical activity, symptom-reporting, and quality of life.
METHODS METHODS
Participants are randomised in a 2 × 2 factorial design to both a physical activity (brisk walking or control) and a pharmacological (metformin or control) intervention. Participants perform the interventions for 6 months with final measures collected at 12 months follow-up.
DISCUSSION CONCLUSIONS
Our trial will determine whether participants diagnosed with localised or locally advanced prostate cancer, who are scheduled for radical treatments or being monitored for signs of cancer progression, can be randomised to a 6 months physical activity and metformin intervention. The findings from our trial will inform a larger trial powered to examine the clinical benefits of these interventions.
TRIAL REGISTRATION BACKGROUND
Prostate Cancer Exercise and Metformin Trial (Pre-EMpT) is registered on the ISRCTN registry, reference number ISRCTN13543667 . Date of registration 2nd August 2018-retrospectively registered. First participant was recruited on 11th September 2018.

Identifiants

DOI: 10.1186/s40814-022-01136-7 PMID: 35962445 PMC: PMC9372971
pubmed: 35962445
doi: 10.1186/s40814-022-01136-7
pii: 10.1186/s40814-022-01136-7
pmc: PMC9372971
doi:

Types de publication

Journal Article

Langues

eng

Pagination

179

Subventions

Organisme : NIHR Biomedical Research Centres Competition 2016
ID : BRC-1215-20011

Informations de copyright

© 2022. The Author(s).

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Auteurs

Lucy McGeagh (L)

NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.
Supportive Cancer Care Research Group, Faculty of Health and Life Sciences, Oxford Institute of Nursing, Midwifery and Allied Health Research, Oxford Brookes University, Oxford, UK.

Luke A Robles (LA)

NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.
ORCID: 0000-0003-2882-9868

Raj Persad (R)

Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.

Edward Rowe (E)

Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.

Amit Bahl (A)

Bristol Haematology and Oncology Centre, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.

Jonathan Aning (J)

Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.

Anthony Koupparis (A)

Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.

Paul Abrams (P)

Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.

Claire Perks (C)

Insulin-like Growth Factors and Metabolic Endocrinology Group, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.

Jeffrey Holly (J)

Insulin-like Growth Factors and Metabolic Endocrinology Group, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.

Lyndsey Johnson (L)

Clinical Research Centre, North Bristol NHS Trust, Bristol, UK.

Constance Shiridzinomwa (C)

Clinical Research Centre, North Bristol NHS Trust, Bristol, UK.

Amarnath Challapalli (A)

Bristol Haematology and Oncology Centre, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.

Ellie Shingler (E)

NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.

Hilary Taylor (H)

NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.
Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK.

Jon Oxley (J)

Department of Cellular Pathology, North Bristol NHS Trust, Bristol, UK.

Meda Sandu (M)

NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.

Richard M Martin (RM)

NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.
Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK.

J Athene Lane (JA)

NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK. Athene.Lane@bristol.ac.uk.
Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK. Athene.Lane@bristol.ac.uk.

Classifications MeSH