Pre- and Post-Operative Exercise Program in Upper Gastrointestinal Cancers (PERIOP-OG)

Royal College of Surgeons, Ireland

Status: Completed

Conditions: Exercise Intervention

Treatments: Behavioral: Standard Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT03807518

RCSI 18/58

Details and patient eligibility

About

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.

Full description

The comparator in this study will be standard oncological care. There patients will receive the exact same care as the intervention group patients but will receive no exercise training program.

The primary goal of this multi-centre randomised controlled trial are to investigate the effects of peri-operative exercise training programmes on physical fitness, measured with a 6 minute walk test, in patients undergoing a major curative upper-GI resection for either oesophageal or gastric cancer.

The secondary aims will look at the effect of peri-operative exercise training on patients quality of life, optimism and well being, post operative morbidity, nutritional status and blood markers of inflammation.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Structured Exercise Intervention

Experimental group

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.

Treatment:

Behavioral: Standard Exercise Program

Standard Oncological Care

No Intervention group

Description:

This group will receive standard oncological care and will receive no formal education of exercise intervention.