Clinical trial · Interventional
Internet-based Perioperative Exercise Program in Patients With Barrett's Carcinoma Scheduled for Esophagectomy
Internet-based Perioperative Exercise Program in Patients With Barrett's Carcinoma Scheduled for Esophagectomy (iPEP Study) A Prospective Randomized-controlled Pilot Trial
NCT02478996CI-TRIAL-00030065iPEPunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Internet-based exercise program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Internet-based exercise program
- 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.
- interventionNames
- Other: Internet-based exercise program
- type
- NO_INTERVENTION
- label
- Basis therapy
- 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.
Primary outcomes (1)
- measure
- peak oxygen uptake (VO2peak)
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (33)
- BACKGROUNDGockel I, Niebisch S, Ahlbrand CJ, Hoffmann C, Mohler M, Duber C, Lang H, Heid F. Risk and Complication Management in Esophageal Cancer Surgery: A Review of the Literature. Thorac Cardiovasc Surg. 2016 Oct;64(7):596-605. doi: 10.1055/s-0034-1399763. Epub 2015 Jan 28. PMID 25629461
- BACKGROUNDvan Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088. PMID 22646630
- BACKGROUNDDerogar M, Orsini N, Sadr-Azodi O, Lagergren P. Influence of major postoperative complications on health-related quality of life among long-term survivors of esophageal cancer surgery. J Clin Oncol. 2012 May 10;30(14):1615-9. doi: 10.1200/JCO.2011.40.3568. Epub 2012 Apr 2. PMID 22473157
- BACKGROUNDBiere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1. PMID 22552194
- BACKGROUNDSchwenk W. [Fast track rehabilitation in visceral surgery]. Chirurg. 2009 Aug;80(8):690-701. doi: 10.1007/s00104-009-1676-1. German. PMID 19568723
- BACKGROUNDBardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4. doi: 10.1016/s0140-6736(95)90643-6.