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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02478996
Recruitment Status : Unknown
Verified October 2017 by Dr. Ines Gockel, University of Leipzig.
Recruitment status was:  Recruiting
First Posted : June 23, 2015
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Ines Gockel, University of Leipzig

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Gastric conduit failure after esophagectomy [ Time Frame: intraoperative ]
    (type classification according to Veeramootoo et al. (2009)) Evaluation of postoperative in-hospital stay

  2. pneumonia [ Time Frame: intraoperative ]
    Evaluation of postoperative in-hospital stay

  3. duration of mechanical ventilation [ Time Frame: intraoperative ]
    Evaluation of postoperative in-hospital stay

  4. re-intubation rate [ Time Frame: intraoperative ]
    Evaluation of postoperative in-hospital stay

  5. Duration of intensive care unit stay [ Time Frame: intraoperative ]
    Evaluation of postoperative in-hospital stay

  6. 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


Other Outcome Measures:
  1. feasibility of the online-based sports program [ Time Frame: 6 months ]
    analysis by written questionnaire



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478996


Contacts
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Contact: Daniel Pfirrmann +49 6131 392 3571 pfirrma@uni-mainz.de

Locations
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Germany
Department of Visceral, Transplantation, Vascular and Thoracic Surgery Recruiting
Leipzig, Germany, 04103
Contact: Ines Gockel    +49 341 - 9717200    chi2@medizin.uni-leipzig.de   
Sponsors and Collaborators
University of Leipzig
Investigators
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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 of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Ines Gockel, Prof. Dr., University of Leipzig
ClinicalTrials.gov Identifier: NCT02478996    
Other Study ID Numbers: AFSM-01
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Keywords provided by Dr. Ines Gockel, University of Leipzig:
perioperative
internet-based
exercise program
Additional relevant MeSH terms:
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Barrett Esophagus
Neoplasms
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases