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

Sponsor

University of Leipzig (Other)

Overall Status

Unknown status

CT.gov ID

NCT02478996

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Barrett Esophagus	Other: Internet-based exercise program	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Internet-based exercise program Patients undergo internet-based perioperative exercise program (iPEP), including daily endurance, resistance and ventilation training
No Intervention: Basis therapy 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.

Arm

Intervention/Treatment

Experimental: 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.

Other: Internet-based exercise program

Patients undergo internet-based perioperative exercise program (iPEP), including daily endurance, resistance and ventilation training

No Intervention: Basis therapy

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.

Outcome Measures

Primary Outcome Measures

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

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
re-intubation rate [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

Other Outcome Measures

feasibility of the online-based sports program [6 months]
analysis by written questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Visceral, Transplantation, Vascular and Thoracic Surgery	Leipzig		Germany	04103

Sponsors and Collaborators

University of Leipzig

Investigators

Principal Investigator: Perikles Simon, Prof.Dr.Dr., Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg-University of Mainz
Principal Investigator: Ines Gockel, Prof. Dr., Department of Visceral, Transplantation, Vascular and Thoracic Surgery, University Hospital of Leipzig