Clinical trial · Interventional
Pre- and Post-Operative Exercise Program in Upper Gastrointestinal Cancers
The Effect of a Pre- and Post- Operative Exercise Programme Versus Standard Care on Physical Fitness in People With Upper Gastrointestinal Cancers- Study Protocol for a Randomised Control Trial: The PERIOP-OG Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Esophageal and gastric cancers are a considerable health burden. In the past 10 years the 5-year survival for both cancers has doubled. This is due to a number of factors including advances in neo adjuvant and adjuvant chemotherapy and radiotherapy. However, physical fitness significantly declines as a result of neo adjuvant an adjuvant therapy. From studies in other cancers it is known that peri operative training improves physical fitness, yet there is little research into its effects in those with upper gastrointestinal cancers. The aim of this study is to assess the effect of a pre-and post operative training program on patients with upper gastrointestinal cancers on their physical fitness and consequently their optimism, quality of life and post operative morbidity.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Exercise Intervention | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Exercise Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Structured Exercise Intervention
- description
- The exercise training program was designed to improve physical fitness while the patients are receiving neoadjuvant treatment prior to surgery and for a 6 week period after surgery once patients are deemed fit to return to training.
- interventionNames
- Behavioral: Standard Exercise Program
- type
- NO_INTERVENTION
- label
- Standard Oncological Care
- description
- This group will receive standard oncological care and will receive no formal education of exercise intervention.
Primary outcomes (1)
- measure
- Change in Physical Fitness
- timeFrame
- Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Be 18 years of age or above; * Have confirmed Multi Disciplinary Team (MDT) evidence of adenocarcinoma or squamous cell cancer of the oesophagus, oesophago- gastric junction or stomach requiring neoadjuvant therapy and planned curative resection. * Be referred by a multidisciplinary team meeting for neo adjuvant chemotherapy or neo adjuvant chemoradiotherapy prior to planned oesophagectomy or gastrectomy. * Have measurement confirming (endoscopic or otherwise) that the tumour starts more than 5cm below cricopharyngeus; * Be fit for pre-operative anaesthesia and surgery * Be able to provide written informed consent. Exclusion Criteria: * Inability to participate in the exercise program (unable to perform 6 Minute Walk Test, unable to attend for assessment of parameters at any time point). * Patients with high grade dysplasia (squamous cell or adenocarcinoma); * Patients who have or develop metastatic disease at time of enrolment or during their neoadjuvant therapy; * Patients being referred for primary surgery without requirement for neoadjuvant treatment; * Patients with squamous cell cancer of the oesophagus who the MDT recommends or who individually elect to undergo definitive chemoradiotherapy; * Evidence of previous/concomitant malignancy that would interfere with this treatment protocol; * Pregnancy; * Patients participating in other trials that would interfere with the implementation of this protocol at a particular site.
References
Publications (2)
- DERIVEDLoughney L, Bolger J, Tully R, Sorensen J, Bambrick M, Carroll PA, Arumugasamy M, Murphy TJ, McCaffrey N, Robb WB; PERIOP-OG Working Group. The effect of a pre-operative 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): a randomized controlled trial. Int J Surg. 2024 Oct 1;110(10):6632-6646. doi: 10.1097/JS9.0000000000001663. PMID 38935085
- DERIVEDTully R, Loughney L, Bolger J, Sorensen J, McAnena O, Collins CG, Carroll PA, Arumugasamy M, Murphy TJ, Robb WB; PERIOP OG Working Group. 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. Trials. 2020 Jul 13;21(1):638. doi: 10.1186/s13063-020-04311-4. PMID 32660526