Back to resultsInternet-based Perioperative Exercise Program in Patients With Barrett's Carcinoma Scheduled for Esophagectomy (iPEP)
Primary Purpose
Barrett Esophagus
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Internet-based exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Barrett Esophagus focused on measuring perioperative, internet-based, exercise program
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
Sites / Locations
- Department of Visceral, Transplantation, Vascular and Thoracic SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Internet-based exercise program
Basis therapy
Arm 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.
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.
Outcomes
Primary Outcome Measures
peak oxygen uptake (VO2peak)
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
(type classification according to Veeramootoo et al. (2009)) Evaluation of postoperative in-hospital stay
pneumonia
Evaluation of postoperative in-hospital stay
duration of mechanical ventilation
Evaluation of postoperative in-hospital stay
re-intubation rate
Evaluation of postoperative in-hospital stay
Duration of intensive care unit stay
Evaluation of postoperative in-hospital stay
quality of life
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02478996
Brief Title
Internet-based Perioperative Exercise Program in Patients With Barrett's Carcinoma Scheduled for Esophagectomy
Acronym
iPEP
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
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus
Keywords
perioperative, internet-based, exercise program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Internet-based exercise program
Arm Type
Experimental
Arm 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.
Arm Title
Basis therapy
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Internet-based exercise program
Intervention Description
Patients undergo internet-based perioperative exercise program (iPEP), including daily endurance, resistance and ventilation training
Primary Outcome Measure Information:
Title
peak oxygen uptake (VO2peak)
Description
First measurement three months prior to surgery (baseline), Second measurement immediately before surgery, third measurement three months after esophagectomy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Gastric conduit failure after esophagectomy
Description
(type classification according to Veeramootoo et al. (2009)) Evaluation of postoperative in-hospital stay
Time Frame
intraoperative
Title
pneumonia
Description
Evaluation of postoperative in-hospital stay
Time Frame
intraoperative
Title
duration of mechanical ventilation
Description
Evaluation of postoperative in-hospital stay
Time Frame
intraoperative
Title
re-intubation rate
Description
Evaluation of postoperative in-hospital stay
Time Frame
intraoperative
Title
Duration of intensive care unit stay
Description
Evaluation of postoperative in-hospital stay
Time Frame
intraoperative
Title
quality of life
Description
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
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
feasibility of the online-based sports program
Description
analysis by written questionnaire
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Pfirrmann
Phone
+49 6131 392 3571
Email
pfirrma@uni-mainz.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perikles Simon, Prof.Dr.Dr.
Organizational Affiliation
Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg-University of Mainz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ines Gockel, Prof. Dr.
Organizational Affiliation
Department of Visceral, Transplantation, Vascular and Thoracic Surgery, University Hospital of Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Visceral, Transplantation, Vascular and Thoracic Surgery
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ines Gockel
Phone
+49 341 - 9717200
Email
chi2@medizin.uni-leipzig.de
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Internet-based Perioperative Exercise Program in Patients With Barrett's Carcinoma Scheduled for Esophagectomy
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