Clinical trial NCT02478996: Internet-based Perioperative Exercise Program in Patients With Barrett's Carcinoma Scheduled for Esophagectomy
Official title: Internet-based Perioperative Exercise Program in Patients With Barrett's Carcinoma Scheduled for Esophagectomy (iPEP Study) A Prospective Randomized-controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Barrett Esophagus
Keywords: perioperative
internet-based
exercise program
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: peak oxygen uptake (VO2peak)
timeFrame: 6 months
Secondary outcomes:
measure: Gastric conduit failure after esophagectomy
timeFrame: intraoperative
measure: pneumonia
timeFrame: intraoperative
measure: duration of mechanical ventilation
timeFrame: intraoperative
measure: re-intubation rate
timeFrame: intraoperative
measure: Duration of intensive care unit stay
timeFrame: intraoperative
measure: quality of life
timeFrame: 6 months
Other outcomes:
measure: feasibility of the online-based sports program
timeFrame: 6 months
Locations:
city: Leipzig
country: Germany
facility: Department of Visceral, Transplantation, Vascular and Thoracic Surgery
Study officials:
affiliation: Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg-University of Mainz
name: Perikles Simon, Prof.Dr.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Visceral, Transplantation, Vascular and Thoracic Surgery, University Hospital of Leipzig
name: Ines Gockel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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