Barrett EsophagusiPEPNCT02478996
Internet-based Perioperative Exercise Program in Patients With Barrett's Carcinoma Scheduled for Esophagectomy
A study testing Internet-based exercise program in people with Barrett Esophagus, run by University of Leipzig at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Internet-based exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Visceral, Transplantation, Vascular and Thoracic Surgery
Leipzig, 04103
Ines Gockel, +49 341 - 9717200, chi2@medizin.uni-leipzig.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Barrett Esophagus
- Being tested
- Internet-based exercise program
- Keywords
- perioperative, internet-based, exercise program
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based exercise programOther
Patients undergo internet-based perioperative exercise program (iPEP), including daily endurance, resistance and ventilation training
| Study group | Role | What they receive |
|---|---|---|
| Internet-based exercise program | Experimental | 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. Receives: Other: Internet-based exercise program |
| Basis therapy | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
peak oxygen uptake (VO2peak)
First measurement three months prior to surgery (baseline), Second measurement immediately before surgery, third measurement three months after esophagectomy
Measured: 6 months
Secondary outcomes (6)
Gastric conduit failure after esophagectomy
(type classification according to Veeramootoo et al. (2009)) Evaluation of postoperative in-hospital stay
Measured: intraoperative
pneumonia
Evaluation of postoperative in-hospital stay
Measured: intraoperative
duration of mechanical ventilation
Evaluation of postoperative in-hospital stay
Measured: intraoperative
re-intubation rate
Evaluation of postoperative in-hospital stay
Measured: intraoperative
Duration of intensive care unit stay
Evaluation of postoperative in-hospital stay
Measured: intraoperative
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ines Gockel, University of Leipzig
- Investigators
- Perikles Simon, Prof.Dr.Dr., Principal investigator, Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg-University of MainzInes Gockel, Prof. Dr., Principal investigator, Department of Visceral, Transplantation, Vascular and Thoracic Surgery, University Hospital of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478996
- Sponsor's protocol ID
- AFSM-01
- Acronym
- iPEP
- Status last verified
- Oct 2017
- First submitted
- 26 May 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
Publications
Gockel 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.
PubMed 25629461van 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.
PubMed 22646630Derogar 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.
PubMed 22473157Biere 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.
PubMed 22552194Schwenk W. [Fast track rehabilitation in visceral surgery]. Chirurg. 2009 Aug;80(8):690-701. doi: 10.1007/s00104-009-1676-1. German.
PubMed 19568723Bardram 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.
PubMed 7891489Cerfolio RJ, Bryant AS, Bass CS, Alexander JR, Bartolucci AA. Fast tracking after Ivor Lewis esophagogastrectomy. Chest. 2004 Oct;126(4):1187-94. doi: 10.1378/chest.126.4.1187.
PubMed 15486381Cao S, Zhao G, Cui J, Dong Q, Qi S, Xin Y, Shen B, Guo Q. Fast-track rehabilitation program and conventional care after esophagectomy: a retrospective controlled cohort study. Support Care Cancer. 2013 Mar;21(3):707-14. doi: 10.1007/s00520-012-1570-0. Epub 2012 Aug 30.
PubMed 22933129Jensen LS, Pilegaard HK, Eliasen M, Mehlsen NC, Kehlet H. [Esophageal resection in an accelerated postoperative recovery regimen]. Ugeskr Laeger. 2004 Jun 21;166(26-31):2560-3. No abstract available. Danish.
PubMed 15285164Neal JM, Wilcox RT, Allen HW, Low DE. Near-total esophagectomy: the influence of standardized multimodal management and intraoperative fluid restriction. Reg Anesth Pain Med. 2003 Jul-Aug;28(4):328-34. doi: 10.1016/s1098-7339(03)00197-4.
PubMed 12945027Blom RL, van Heijl M, Bemelman WA, Hollmann MW, Klinkenbijl JH, Busch OR, van Berge Henegouwen MI. Initial experiences of an enhanced recovery protocol in esophageal surgery. World J Surg. 2013 Oct;37(10):2372-8. doi: 10.1007/s00268-013-2135-1.
PubMed 23807122Veeramootoo D, Parameswaran R, Krishnadas R, Froeschle P, Cooper M, Berrisford RG, Wajed SA. Classification and early recognition of gastric conduit failure after minimally invasive esophagectomy. Surg Endosc. 2009 Sep;23(9):2110-6. doi: 10.1007/s00464-008-0233-1. Epub 2008 Dec 6.
PubMed 19067058Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
PubMed 8433390Kondrup J, Allison SP, Elia M, Vellas B, Plauth M; Educational and Clinical Practice Committee, European Society of Parenteral and Enteral Nutrition (ESPEN). ESPEN guidelines for nutrition screening 2002. Clin Nutr. 2003 Aug;22(4):415-21. doi: 10.1016/s0261-5614(03)00098-0.
PubMed 12880610Martin L, Birdsell L, Macdonald N, Reiman T, Clandinin MT, McCargar LJ, Murphy R, Ghosh S, Sawyer MB, Baracos VE. Cancer cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol. 2013 Apr 20;31(12):1539-47. doi: 10.1200/JCO.2012.45.2722. Epub 2013 Mar 25.
PubMed 23530101
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Perioperative Exercise Program in Patients With Barrett's Carcinoma Scheduled for Esophagectomy (iPEP Study) A Prospective Randomized-controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT02478996
- Acronym / sponsor ID
- iPEP / AFSM-01
- Conditions
- Barrett Esophagus
- Keywords
- perioperative, internet-based, exercise program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based exercise program | Experimental | Other: Internet-based exercise programThe 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. |
| Basis therapy | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based exercise programPatients undergo internet-based perioperative exercise program (iPEP), including daily endurance, resistance and ventilation training | Other | Internet-based exercise program |
Primary outcome
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 secondary outcomes
Gastric conduit failure after esophagectomy
Time frame: intraoperative
pneumonia
Time frame: intraoperative
duration of mechanical ventilation
Time frame: intraoperative
re-intubation rate
Time frame: intraoperative
Duration of intensive care unit stay
Time frame: intraoperative
quality of life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Background: PubMed 25629461Gockel 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.
- Background: PubMed 22646630van 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.
- Background: PubMed 22473157Derogar 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.
- Background: PubMed 22552194Biere 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.
- Background: PubMed 19568723Schwenk W. [Fast track rehabilitation in visceral surgery]. Chirurg. 2009 Aug;80(8):690-701. doi: 10.1007/s00104-009-1676-1. German.
- Background: PubMed 7891489Bardram 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.
- Background: PubMed 15486381Cerfolio RJ, Bryant AS, Bass CS, Alexander JR, Bartolucci AA. Fast tracking after Ivor Lewis esophagogastrectomy. Chest. 2004 Oct;126(4):1187-94. doi: 10.1378/chest.126.4.1187.
- Background: PubMed 22933129Cao S, Zhao G, Cui J, Dong Q, Qi S, Xin Y, Shen B, Guo Q. Fast-track rehabilitation program and conventional care after esophagectomy: a retrospective controlled cohort study. Support Care Cancer. 2013 Mar;21(3):707-14. doi: 10.1007/s00520-012-1570-0. Epub 2012 Aug 30.
- Background: PubMed 15285164Jensen LS, Pilegaard HK, Eliasen M, Mehlsen NC, Kehlet H. [Esophageal resection in an accelerated postoperative recovery regimen]. Ugeskr Laeger. 2004 Jun 21;166(26-31):2560-3. No abstract available. Danish.
- Background: PubMed 12945027Neal JM, Wilcox RT, Allen HW, Low DE. Near-total esophagectomy: the influence of standardized multimodal management and intraoperative fluid restriction. Reg Anesth Pain Med. 2003 Jul-Aug;28(4):328-34. doi: 10.1016/s1098-7339(03)00197-4.
- Background: PubMed 23807122Blom RL, van Heijl M, Bemelman WA, Hollmann MW, Klinkenbijl JH, Busch OR, van Berge Henegouwen MI. Initial experiences of an enhanced recovery protocol in esophageal surgery. World J Surg. 2013 Oct;37(10):2372-8. doi: 10.1007/s00268-013-2135-1.
- Background: PubMed 19067058Veeramootoo D, Parameswaran R, Krishnadas R, Froeschle P, Cooper M, Berrisford RG, Wajed SA. Classification and early recognition of gastric conduit failure after minimally invasive esophagectomy. Surg Endosc. 2009 Sep;23(9):2110-6. doi: 10.1007/s00464-008-0233-1. Epub 2008 Dec 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perikles Simon, Prof.Dr.Dr. principal investigator
Department of Sports Medicine, Disease Prevention and Rehabilitation, Johannes Gutenberg-University of Mainz
Ines Gockel, Prof. Dr. principal investigator
Department of Visceral, Transplantation, Vascular and Thoracic Surgery, University Hospital of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based exercise program in people with Barrett Esophagus, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Pfirrmann (+49 6131 392 3571, pfirrma@uni-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak oxygen uptake (VO2peak) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02478996, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.