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

University of Leipzig

Status: Unknown

Conditions: Barrett Esophagus

Treatments: Other: Internet-based exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT02478996

AFSM-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Internet-based exercise program

Experimental group

Description:

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.

Treatment:

Other: Internet-based exercise program

Basis therapy

No Intervention group

Description:

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.