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

NCT ID: NCT03807518

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-03-01

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.

Detailed 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.

Conditions

Exercise Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Structured Exercise Intervention

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.

Group Type: EXPERIMENTAL

Standard Exercise Program

Intervention Type: 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.

Standard Oncological Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Standard Exercise Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beaumont Hospital

OTHER

Sponsor Role: collaborator

Mercy University Hospital, Cork, Ireland

OTHER

Sponsor Role: collaborator

Dublin City University

OTHER

Sponsor Role: collaborator

Royal College of Surgeons, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital Dublin

Noel McCaffrey, MB,BCh,BAO,BSc,MSc

Role: STUDY_CHAIR

Dublin City University

Thomas Murphy, MB,BCh,BAO,FRCSI

Role: STUDY_CHAIR

Mercy University Hospital, Cork

Jarlath Bolger, MB,BCh,BAO,MD

Role: STUDY_CHAIR

Beaumont Hospital

Pamela Gallagher, Professor of Psychology

Role: STUDY_CHAIR

Dublin City University

Claire Timon, BSc,PhD

Role: STUDY_CHAIR

University College Dublin

Jan Sorensen, MSc, MA

Role: STUDY_CHAIR

Royal College of Surgeons, Ireland

Locations

Beaumont Hospital

Dublin, , Ireland

Countries

Ireland

References

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.

Reference Type: DERIVED

PMID: 38935085 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32660526 (View on PubMed)

Other Identifiers

RCSI 18/58

Identifier Type: -

Identifier Source: org_study_id