Pre- and Post-Operative Exercise Program in Upper Gastrointestinal Cancers

NCT03807518 | Completed DMC

• 1 other identifier: RCSI 18/58
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Exercise Intervention

Keywords

Oesophageal Cancer; Gastric Cancer; Physical Fitness

Outcome Measures

Primary Outcomes (1)

• Change in Physical Fitness

  The primary goal of this multi-centre randomised controlled trial is to investigate the effects of peri-operative exercise training programmes on physical fitness, defined as the distance covered in metres and centimetres during a 6 minute walk test, in patients undergoing a major curative upper-GI resection for either oesophageal or gastric cancer. To complete the Six Minute Walk Test, no warm up is permitted and participants rest in a seated position for 10 minutes prior to the test beginning. Participants walk up and down a 20m course marked by cones for 6 minutes under instruction to cover as much ground as possible. The number of laps completed is recorded. A standard set of instructions as well as encouragement is used. After 6 minutes, the participant stops and the distance covered in the final partial lap as measured and total distance covered is calculated. Change from baseline to post treatment difference between groups.

  Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery

Secondary Outcomes (19)

• Change in Strength - The Sit to Stand Test

  Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery

• Change in Strength - The Handgrip Test

  Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery

• Change in Body Composition

  Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery

• Change in Physical Activity - Accelerometer

  Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery

• Change in Quality of Life measured using the EQ-5D Health Questionnaire

  Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery

Study Arms (2)

Structured Exercise Intervention

EXPERIMENTAL

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.

Behavioral: Standard Exercise Program

Standard Oncological Care

NO INTERVENTION

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

Interventions

Standard Exercise Program BEHAVIORAL

Standard Exercise Program- Participants will be invited to take part in a structured home, supervised, or both, exercise program while undergoing neo adjuvant therapy and for a six week period when deemed fit post surgery.

Structured Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Beaumont Hospital: collaborator
• Mercy University Hospital, Cork, Ireland: collaborator
• Dublin City University: collaborator

Study Sites (1)

Beaumont Hospital

Dublin, Ireland

Location

Related Publications (2)

• Loughney 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 DERIVED

• Tully 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 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• William Robb, MB,BCh,BAO,BA,FRCSI,MD

  Beaumont Hospital Dublin

  PRINCIPAL INVESTIGATOR

• Noel McCaffrey, MB,BCh,BAO,BSc,MSc

  Dublin City University

  STUDY CHAIR

• Thomas Murphy, MB,BCh,BAO,FRCSI

  Mercy University Hospital, Cork

  STUDY CHAIR

• Jarlath Bolger, MB,BCh,BAO,MD

  Beaumont Hospital

  STUDY CHAIR

• Pamela Gallagher, Professor of Psychology

  Dublin City University

  STUDY CHAIR

• Claire Timon, BSc,PhD

  University College Dublin

  STUDY CHAIR

• Jan Sorensen, MSc, MA

  Royal College of Surgeons, Ireland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator will be blinded to the allocation of the participants
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group randomised 1:1 controlled multi centre trial

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: January 17, 2019
• Study Start: March 1, 2019
• Primary Completion: December 19, 2020
• Study Completion: March 1, 2021
• Last Updated: March 9, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)