Internet-based Perioperative Exercise Program in Patients With Barrett's Carcinoma Scheduled for Esophagectomy

Study Overview
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Brief Summary
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This study will evaluate, if an intensive individually adaptated training program via online supervision during neoadjuvant therapy will improve lung function and reduce pulmonary complications following esophagectomy for Barrett's cancer.

Detailed Description
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Patients undergoing surgery for esophageal cancer have a high risk for postoperative deterioration of lung function and pulmonal complications. This may be partly due to one-lung ventilation during the thoracic part of the operation. This often encounters for prolonged periods of reconvalescence and reduced quality of life, apart from socioeconomic disadvantages. Physical preconditioning has become a crucial leverage to optimize fitness and lung function in patients scheduled for esophagectomy, in particular during the interval of neoadjuvant therapy.

Official Title
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Internet-based Perioperative Exercise Program in Patients With Barrett's Carcinoma Scheduled for Esophagectomy (iPEP Study) A Prospective Randomized-controlled Pilot Trial

Conditions
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Barrett Esophagus

Intervention / Treatment
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* Other: Internet-based exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven adenocarcinoma of the esophagus or adenocarcinoma of the esophagogastric junction type I according to Siewert's classification, clinical stages IIB-IIIC (T3/T4 and/or N+; M0) according to Union Internationale Contre le Cancer (UICC), 7th Edition Resectable stage according to discussion in the local multidisciplinary tumor board (MDT) of the participating centers and patient medically fit for multimodality therapy (ECOG performance status at least 1 or better, no severe impairment of cardiac, renal, hepatic, endocrine, bone marrow and cerebral functions) Planned abdominal-thoracic esophagectomy with gastric pull-up and intrathoracic or cervical anastomosis Cognitive ability of the patient to understand the perioperative program and to participate actively Exclusion Criteria: Presence of a second malignant tumor (unless curatively treated > 5 years ago) Chemotherapy or radiochemotherapy in patient's history Orthopedic, rheumatologic, cardiovascular or neurologic (epilepsy, stroke, Parkinson's disease, muscle wasting diseases such as amyotrophic lateral sclerosis or multiple sclerosis) contraindications for the sports program Inability to use the internet or no internet Access Inability to communicate in German Each active disease, which hinders completion of the study Active alcoholism or illegal drug consumption within the last six months before study entry

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based exercise program<br>The intervention group is supervised by a sports scientist eight to twelve weeks before and after surgery. Patients receive an individually designed intensive exercise program based on the functional and Fitness measurements at first diagnosis. | Other: Internet-based exercise program<br>* Patients undergo internet-based perioperative exercise program (iPEP), including daily endurance, resistance and ventilation training<br>|
| No Intervention: Basis therapy<br>Participants of the Treatment as usual (TAU) group receive written information material enlightening the importance of regular physical activities and general releases on preparation for esophagectomy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak oxygen uptake (VO2peak) | First measurement three months prior to surgery (baseline), Second measurement immediately before surgery, third measurement three months after esophagectomy | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric conduit failure after esophagectomy | (type classification according to Veeramootoo et al. (2009)) Evaluation of postoperative in-hospital stay | intraoperative | 
| pneumonia | Evaluation of postoperative in-hospital stay | intraoperative | 
| duration of mechanical ventilation | Evaluation of postoperative in-hospital stay | intraoperative | 
| re-intubation rate | Evaluation of postoperative in-hospital stay | intraoperative | 
| Duration of intensive care unit stay | Evaluation of postoperative in-hospital stay | intraoperative | 
| quality of life | Quality of life questionnaire (QoLQ-C30) with the esophagus-specific module OES-18. First measurement three months prior to surgery (baseline), immediately before surgery, three months after esophagectomy | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perioperative, internet-based, exercise program