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

Not Applicable

• Conditions: Barrett Esophagus
• Interventions: Other: Internet-based exercise program

• Registration Number: NCT02478996
• Lead Sponsor: University of Leipzig

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-23
• Study Start: 2015-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26
• Primary Completion: 2018-12
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-based exercise program	Internet-based exercise program	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.

Primary Outcome Measures

Name	Time	Method
peak oxygen uptake (VO2peak)	6 months	First measurement three months prior to surgery (baseline), Second measurement immediately before surgery, third measurement three months after esophagectomy

Secondary Outcome Measures

Name	Time	Method
re-intubation rate	intraoperative	Evaluation of postoperative in-hospital stay
quality of life	6 months	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
Gastric conduit failure after esophagectomy	intraoperative	(type classification according to Veeramootoo et al. (2009)) Evaluation of postoperative in-hospital stay
pneumonia	intraoperative	Evaluation of postoperative in-hospital stay
duration of mechanical ventilation	intraoperative	Evaluation of postoperative in-hospital stay
Duration of intensive care unit stay	intraoperative	Evaluation of postoperative in-hospital stay

Trial Locations

Locations (1)

Department of Visceral, Transplantation, Vascular and Thoracic Surgery; 🇩🇪 Leipzig, Germany