The effect of a pre- and post- operative exercise programme versus standard care on physical fitness of patients with oesophageal and gastric cancer undergoing neoadjuvant treatment prior to surgery (The PERIOP-OG Trial): Study protocol for a randomised controlled trial.

Abstract

Background: Advances in peri-operative oncological treatment, surgery and peri-operative care have improved survival for patients with oesophagogastric cancers. Neoadjuvant cancer treatment (NCT) reduces physical fitness, which may reduce both compliance and tolerance of NCT as well as compromising post-operative outcomes. This is particularly detrimental in a patient group where malnutrition is common and surgery is demanding. The aim of this trial is to assess the effect on physical fitness and clinical outcomes of a comprehensive exercise training programme in patients undergoing NCT and surgical resection for oesophagogastric malignancies. Methods: The PERIOP-OG trial is a pragmatic, multi-centre, randomised controlled trial comparing a programme of peri-operative exercise with standard care in patients with oesophagogastric cancers treated with NCT and surgery. The intervention group undergo a formal exercise training programme and the usual care group receive standard clinical care (no formal exercise advice). The training programme is initiated at cancer diagnosis, continued during NCT, between NCT and surgery, and then resumed again after surgery. All participants undergo assessments at: baseline, post-NCT, pre-surgery and at 4 and 10 weeks after surgery. The primary endpoint is cardiorespiratory fitness measured by demonstration of a 15% difference in 6-minute walk test assessed at the pre-surgery time point. Secondary endpoints include measures of physical health (upper and lower body strength tests), body mass index, frailty, activity behavior, psychological and health related quality of life outcomes. Exploratory endpoints include a health economics analysis, assessment of clinical health by post-operative morbidity scores, hospital length of stay, nutritional status, immune and inflammatory markers, and response to NCT. Rates of NCT toxicity, tolerance and compliance will also be assessed. Discussion: The PERIOP-OG trial will determine whether, when compared to usual care, exercise training initiated at diagnosis and continued during NCT, prior to surgery and then during recovery, can maintain or improve cardiorespiratory fitness and other physical, psychological and clinical health outcomes. This trial will inform both the prescription of exercise regimes as well as the design of a larger prehabilitation and rehabilitation trial to investigate whether exercise in combination with nutritional and psychological interventions elicit greater benefits.

Subjective Gait Speed and Risk of Developing Cardiovascular Events in 56,589 Cancer Survivors

“…20) In particular, subgroup analyses showed that the relationship between gait speed and incident CVD is more pronounced in female or elderly patients, suggesting that these subgroups could be more adequate targets for rehabilitation. Currently, there are many on-going studies examining the efficacy of rehabilitation in patients with cancer, [21][22][23] and we need to accumulate clinical data regarding the impact (not only efficacy but also safety) of rehabilitation on CVD outcomes in cancer survivors. Recently, a comprehensive model (i.e., cardiac oncology rehabilitation [CORE]) has been proposed to prevent or reduce cardiovascular events using a multimodality approach of cardiac rehabilitation in cancer patients.…”

Patients Undergoing Systemic Anti-Cancer Therapy Who Require Surgical Intervention: What Surgeons Need to Know

“…Further analysis of the impact of exercise therapy on surgical fitness after neoadjuvant chemotherapy, in the randomised prospective setting, may be beneficial. The PERIOP-OG trial is an RCT designed to investigate this in a cohort of 72 participants with upper gastrointestinal cancers, and results are awaited [37] (NCT03807518).…”