Barrett Esophagus
Conditions
Keywords
perioperative, internet-based, exercise program
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.
Interventions
OTHERInternet-based exercise program
Patients undergo internet-based perioperative exercise program (iPEP), including daily endurance, resistance and ventilation training
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| re-intubation rate | intraoperative | Evaluation of postoperative in-hospital stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| feasibility of the online-based sports program | 6 months | analysis by written questionnaire |
Countries
Germany
Contacts
Primary ContactDaniel Pfirrmann
Outcome results
None listed