Clinical trial NCT03807518: Pre- and Post-Operative Exercise Program in Upper Gastrointestinal Cancers
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Intervention
Keywords: Oesophageal Cancer
Gastric Cancer
Physical Fitness
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: Beaumont Hospital
name: Mercy University Hospital, Cork, Ireland
name: Dublin City University
First posted: 2019-01-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group randomised 1:1 controlled multi centre trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
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
Secondary outcomes:
measure: Change in Strength - The Sit to Stand Test
timeFrame: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery
measure: Change in Strength - The Handgrip Test
timeFrame: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery
measure: Change in Body Composition
timeFrame: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery
measure: Change in Physical Activity - Accelerometer
timeFrame: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery
measure: Change in Quality of Life measured using the EQ-5D Health Questionnaire
timeFrame: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery
measure: Change in Optimism
timeFrame: Baseline, Change from baseline to one week before surgery
measure: Change in Well Being-The Functional Assessment of Cancer Therapy (FACT-E) questionnaire.
timeFrame: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery
measure: Well Being - Semi-structured Interviews.
timeFrame: One week before surgery
measure: Change in Well Being - Self-efficacy (General Self Efficacy Scale)
timeFrame: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery
measure: Change in Well Being - Mastery (Pearlin Mastery Scale).
timeFrame: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, six weeks after surgery, twelve weeks after surgery
measure: Fear of Surgery Questionnaire
timeFrame: One week before surgery
measure: Post Operative Morbidity - Post Operative Morbidity Score (POMS)
timeFrame: Day 15 post surgery
measure: Post Operative Morbidity - Post Operative Morbidity Score (POMS)
timeFrame: Day 30 post surgery
measure: Post Operative Morbidity -Clavien-Dindo Classification of Surgical Outcomes
timeFrame: Day 15 post surgery
measure: Post Operative Morbidity -Clavien-Dindo Classification of Surgical Outcomes
timeFrame: Day 30 post surgery
measure: Change in Nutritional Status -Assessed using Glasgow Prognostic Score
timeFrame: Baseline, one week after completion of neo adjuvant treatment, one week before surgery,15 days after surgery, 30 days after surgery, six weeks after surgery, twelve weeks after surgery
measure: Change in Nutritional Status -Assessed using Foodbook 24
timeFrame: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, 15 days after surgery, 30 days after surgery, weeks after surgery, twelve weeks after surgery
measure: Change in concentration of blood markers of Inflammation- C-Reactive Protein
timeFrame: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, 15 days after surgery, 30 days after surgery, six weeks after surgery, twelve weeks after surgery
measure: Change in concentration of blood markers of Inflammation- White Cell Differential
timeFrame: Baseline, one week after completion of neo adjuvant treatment, one week before surgery, 15 days after surgery, 30 days after surgery, six weeks after surgery, twelve weeks after surgery
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: Beaumont Hospital Dublin
name: William Robb, MB,BCh,BAO,BA,FRCSI,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dublin City University
name: Noel McCaffrey, MB,BCh,BAO,BSc,MSc
role: STUDY_CHAIR
affiliation: Mercy University Hospital, Cork
name: Thomas Murphy, MB,BCh,BAO,FRCSI
role: STUDY_CHAIR
affiliation: Beaumont Hospital
name: Jarlath Bolger, MB,BCh,BAO,MD
role: STUDY_CHAIR
affiliation: Dublin City University
name: Pamela Gallagher, Professor of Psychology
role: STUDY_CHAIR
affiliation: University College Dublin
name: Claire Timon, BSc,PhD
role: STUDY_CHAIR
affiliation: Royal College of Surgeons, Ireland
name: Jan Sorensen, MSc, MA
role: STUDY_CHAIR
References:
citation: 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.