Exercise training in oesophageal/gastric cancer patient
Research type
Research Study
Full title
The Efficacy of aN exercise training programme during COncurrent neoadjUvant canceR treAtments prior to oesophageal or Gastric cancEr surgery to improve surgical and cancer outcomes.
IRAS ID
191831
Contact name
Sandy Jack
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Cancers of the gullet (oesophagus) and stomach (gastric) combined are the sixth most common cause of cancer-death worldwide. Many of those affected are elderly and physically unfit, putting them at high risk of complications. If patients are fit enough, treatment of oesophagus and stomach (OG) cancer often involves chemotherapy given before surgery (neoadjuvant chemotherapy, NAC) or chemotherapy combined with radiotherapy (CRT) followed by surgery. We have shown that NAC/CRT makes patients become less fit while receiving treatment and have worse outcomes following surgery.
We have successfully carried out an in-hospital exercise training programme (SRETP) research study performed after CRT prior to surgery (in advanced rectal cancer patients), and during NAC (in non-operable lung cancer patients).
This project aims to conduct a 2 phase study. Phase I is a non-randomised feasibility and tolerability study in 6 patients and Phase II a Pilot randomised controlled trial in 24 patients. We aim to deliver a supervised in-hospital Structured Responsive Exercise Training Programme (SRETP) on a static bike delivered by exercise physiologists/nurses (3 sessions of exercise before NAC/CRT, and thereafter two sessions per week during NAC/CRT (up to 7 weeks) followed by 3 times a week until surgery) in patients with oesophageal or stomach cancer prior to surgery to assess the feasibility and tolerability of SRETP. If this phase is successful (≥74% adherence to SRETP and no adverse events attributable to CPET or SRETP.) we will proceed with phase II. This pilot randomised controlled study is in 24 patients will investigate the effects of SRETP vs control patients who will receive standard clinical care with no formal exercise-training. Primary outcome will be improvement of oxygen uptake at anaerobic threshold. CPET variables, physical activity, morbidity, sarcopenia on CT scan, toxicity (measured by AEs and SAEs of NAC/CRT tumour down-staging, tumour regression, disability adjusted survival (WHODAS) and overall survival.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
15/SC/0784
Date of REC Opinion
9 Feb 2016
REC opinion
Favourable Opinion