NCT03509428: WesFit

The Wessex Fit-4-Cancer Surgery Trial

Status unknown NA Last updated 9 May 2019

What this trial tests

NA trial testing SRETP in Cancer in 1,560 participants. Status unknown.

Timeline

26 March 2018

Primary endpoint
1 March 2021

1 March 2022

Quick facts

Lead sponsor	University Hospital Southampton NHS Foundation Trust
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	treatment
Enrollment	1,560
Start date	26 March 2018
Primary completion	1 March 2021
Estimated completion	1 March 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• SRETP
• Psychological support

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

University Hospital Southampton NHS Foundation Trust

Who can join

18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Trial Phase: Phase III: A multi-centre efficacy pragmatic factorial design randomised controlled trial with patient informed development and process evaluation

Indication: Patients undergoing major electively resectable intra - cavity cancer surgery with or without neoadjuvant cancer treatments (including chemotherapy (NAC), chemoradiotherapy (CRT), or immunotherapy).

Objective: To investigate the efficacy of a community based Structured Responsive Exercise-training Programme (SRETP) ± psychological support on surgical outcome by reducing postoperative length of stay (LOS) and complications.

Secondary Objective:

To investigate the efficacy of a community based Structured Responsive Exercise-training Programme (SRETP) ± psychological support to improve disease-free overall survival. Cardiopulmonary Exercise test (CPET) variables, physical activity, morbidity, radiological markers of sarcopenia, toxicity, tumour down-staging, tumour regression, disability adjusted survival (WHODAS) overall survival and quality of life (QoL).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of Prehabilitation Including Exercise on Postoperative Outcomes Following Abdominal Cancer Surgery: A Systematic Review and Meta-Analysis.
   Waterland JL, McCourt O, Edbrooke L, Granger CL, et al · · 2021 · cited 126× · PMID 33816546 · DOI 10.3389/fsurg.2021.628848
2. 'Fit for surgery': the relationship between cardiorespiratory fitness and postoperative outcomes.
   Rose GA, Davies RG, Appadurai IR, Williams IM, et al · · 2022 · cited 35× · PMID 35579479 · DOI 10.1113/ep090156
3. Exercise interventions for people undergoing multimodal cancer treatment that includes surgery.
   Loughney LA, West MA, Kemp GJ, Grocott MP, et al · · 2018 · cited 29× · PMID 30536366 · DOI 10.1002/14651858.cd012280.pub2
4. The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients: a randomised controlled trial (The EMPOWER Trial).
   Loughney L, West MA, Moyses H, Bates A, et al · · 2021 · cited 28× · PMID 34154675 · DOI 10.1186/s13741-021-00190-8
5. The time course of physiological adaptations to high-intensity interval training in older adults.
   Herrod PJJ, Blackwell JEM, Boereboom CL, Atherton PJ, et al · · 2020 · cited 17× · PMID 33392430 · DOI 10.1002/agm2.12127
6. The Wessex Fit-4-Cancer Surgery Trial (WesFit): a protocol for a factorial-design, pragmatic randomised-controlled trial investigating the effects of a multi-modal prehabilitation programme in patients undergoing elective major intra-cavity cancer surgery.
   West M, Bates A, Grimmett C, Allen C, et al · · 2021 · cited 13× · PMID 36247802 · DOI 10.12688/f1000research.55324.2
7. Multivisceral Resection of Advanced Pelvic Tumors: From Planning to Implementation.
   Mirnezami R, Mirnezami A. · · 2020 · cited 6× · PMID 32968362 · DOI 10.1055/s-0040-1713744
8. The Wessex Fit-4-Cancer Surgery Trial (WesFit): a protocol for a factorial-design, pragmatic randomised-controlled trial investigating the effects of a multi-modal prehabilitation programme in patients undergoing elective major intra–cavity cancer surgery
   West M, Bates A, Grimmett C, Allen C, et al · · 2022 · DOI 10.12688/f1000research.55324.2