Status:
COMPLETED
Pre- and Post-Operative Exercise Program in Upper Gastrointestinal Cancers
Lead Sponsor:
Royal College of Surgeons, Ireland
Collaborating Sponsors:
Beaumont Hospital
Mercy University Hospital, Cork, Ireland
Conditions:
Exercise Intervention
Eligibility:
All Genders
18+ years
Phase:
NA
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 adj...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03807518
Start Date
March 1 2019
End Date
March 1 2021
Last Update
March 9 2021
Active Locations (1)
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1
Beaumont Hospital
Dublin, Ireland