Internet-based Perioperative Exercise Program in Patients With Barrett's Carcinoma Scheduled for Esophagectomy (iPEP Study) A Prospective Randomized-controlled Pilot Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Barrett Esophagus
- Sponsor
- University of Leipzig
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- peak oxygen uptake (VO2peak)
- Last Updated
- 8 years ago
Overview
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.
Investigators
Dr. Ines Gockel
Prof. Dr.
University of Leipzig
Eligibility Criteria
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
Outcomes
Primary Outcomes
peak oxygen uptake (VO2peak)
Time Frame: 6 months
First measurement three months prior to surgery (baseline), Second measurement immediately before surgery, third measurement three months after esophagectomy
Secondary Outcomes
- re-intubation rate(intraoperative)
- quality of life(6 months)
- Gastric conduit failure after esophagectomy(intraoperative)
- pneumonia(intraoperative)
- duration of mechanical ventilation(intraoperative)
- Duration of intensive care unit stay(intraoperative)