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

October 25, 2017 updated by: Dr. Ines Gockel, University of Leipzig

Internet-based Perioperative Exercise Program in Patients With Barrett's Carcinoma Scheduled for Esophagectomy (iPEP Study) A Prospective Randomized-controlled Pilot Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04103
        • Recruiting
        • Department of Visceral, Transplantation, Vascular and Thoracic Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric conduit failure after esophagectomy
Time Frame: intraoperative
(type classification according to Veeramootoo et al. (2009)) Evaluation of postoperative in-hospital stay
intraoperative
pneumonia
Time Frame: intraoperative
Evaluation of postoperative in-hospital stay
intraoperative
duration of mechanical ventilation
Time Frame: intraoperative
Evaluation of postoperative in-hospital stay
intraoperative
re-intubation rate
Time Frame: intraoperative
Evaluation of postoperative in-hospital stay
intraoperative
Duration of intensive care unit stay
Time Frame: intraoperative
Evaluation of postoperative in-hospital stay
intraoperative
quality of life
Time Frame: 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
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
feasibility of the online-based sports program
Time Frame: 6 months
analysis by written questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFSM-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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