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

Barrett Esophagus Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02478996
• Other study ID #: AFSM-01
• Status: Recruiting
• Phase: N/A
• First received: May 26, 2015
• Last updated: October 25, 2017
• Start date: August 2015
• Est. completion date: June 2019

Study information

• Verified date: October 2017
• Source: University of Leipzig
• Contact: Daniel Pfirrmann
• Phone: +49 6131 392 3571
• Email: pfirrma[@]uni-mainz.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

Other:
• Internet-based exercise program
Patients undergo internet-based perioperative exercise program (iPEP), including daily endurance, resistance and ventilation training

Locations

Country	Name	City	State
Germany	Department of Visceral, Transplantation, Vascular and Thoracic Surgery	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

References & Publications (31)

Aaronson 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. — View Citation

Agrelli TF, de Carvalho Ramos M, Guglielminetti R, Silva AA, Crema E. Preoperative ambulatory inspiratory muscle training in patients undergoing esophagectomy. A pilot study. Int Surg. 2012 Jul-Sep;97(3):198-202. doi: 10.9738/CC136.1. — View Citation

Bardram 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. — View Citation

Biere 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. — View Citation

Blom 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. — View Citation

Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81. — View Citation

Cao 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. — View Citation

Cerfolio RJ, Bryant AS, Bass CS, Alexander JR, Bartolucci AA. Fast tracking after Ivor Lewis esophagogastrectomy. Chest. 2004 Oct;126(4):1187-94. — View Citation

Derogar 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. — View Citation

Dettling DS, van der Schaaf M, Blom RL, Nollet F, Busch OR, van Berge Henegouwen MI. Feasibility and effectiveness of pre-operative inspiratory muscle training in patients undergoing oesophagectomy: a pilot study. Physiother Res Int. 2013 Mar;18(1):16-26. — View Citation

Feeney C, Reynolds JV, Hussey J. Preoperative physical activity levels and postoperative pulmonary complications post-esophagectomy. Dis Esophagus. 2011 Sep;24(7):489-94. doi: 10.1111/j.1442-2050.2010.01171.x. Epub 2011 Feb 10. — View Citation

Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Piña IL, Rodney R, Simons-Morton DA, Williams MA, Bazzarre T. Exercise standards for testing and training: a statement for healthcare professionals from the American Heart Association. Circulation. 2001 Oct 2;104(14):1694-740. — View Citation

Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. — View Citation

Gockel I, Niebisch S, Ahlbrand CJ, Hoffmann C, Möhler M, Düber 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. Epub 2015 Jan 28. Review. — View Citation

Inoue J, Ono R, Makiura D, Kashiwa-Motoyama M, Miura Y, Usami M, Nakamura T, Imanishi T, Kuroda D. Prevention of postoperative pulmonary complications through intensive preoperative respiratory rehabilitation in patients with esophageal cancer. Dis Esopha — View Citation

Jensen 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. Danish. — View Citation

Kinugasa S, Tachibana M, Yoshimura H, Ueda S, Fujii T, Dhar DK, Nakamoto T, Nagasue N. Postoperative pulmonary complications are associated with worse short- and long-term outcomes after extended esophagectomy. J Surg Oncol. 2004 Nov 1;88(2):71-7. — View Citation

Kondrup 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. — View Citation

Kumagai K, Rouvelas I, Tsai JA, Mariosa D, Klevebro F, Lindblad M, Ye W, Lundell L, Nilsson M. Meta-analysis of postoperative morbidity and perioperative mortality in patients receiving neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal and gastro-oesophageal junctional cancers. Br J Surg. 2014 Mar;101(4):321-38. doi: 10.1002/bjs.9418. Epub 2014 Feb 3. Review. — View Citation

Martin 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. — View Citation

Neal 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. — View Citation

Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, Bandera EV, Hamilton KK, Grant B, McCullough M, Byers T, Gansler T. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012 Jul-Aug;62(4):243-74. doi: 10.3322/caac.21142. Epub 2012 Apr 26. Review. Erratum in: CA Cancer J Clin. 2013 May;63(3):215. — View Citation

Schwenk W. [Fast track rehabilitation in visceral surgery]. Chirurg. 2009 Aug;80(8):690-701. doi: 10.1007/s00104-009-1676-1. Review. German. — View Citation

Tatematsu N, Park M, Tanaka E, Sakai Y, Tsuboyama T. Association between physical activity and postoperative complications after esophagectomy for cancer: a prospective observational study. Asian Pac J Cancer Prev. 2013;14(1):47-51. — View Citation

Trappe HJ, Löllgen H. [Guidelines for ergometry. German Society of Cardiology--Heart and Cardiovascular Research]. Z Kardiol. 2000 Sep;89(9):821-31. German. — View Citation

Valkenet K, Trappenburg JC, Gosselink R, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJ, de Heus SC, Reynolds JV, Guinan E, Ruurda JP, Rodrigo EH, Nafteux P, Fontaine M, Kouwenhoven EA, Kerkemeyer M, van der Peet DL, Hania SW, van Hillegersberg R, — View Citation

Valkenet K, van de Port IG, Dronkers JJ, de Vries WR, Lindeman E, Backx FJ. The effects of preoperative exercise therapy on postoperative outcome: a systematic review. Clin Rehabil. 2011 Feb;25(2):99-111. doi: 10.1177/0269215510380830. Epub 2010 Nov 8. Re — View Citation

van Adrichem EJ, Meulenbroek RL, Plukker JT, Groen H, van Weert E. Comparison of two preoperative inspiratory muscle training programs to prevent pulmonary complications in patients undergoing esophagectomy: a randomized controlled pilot study. Ann Surg O — View Citation

van 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. — View Citation

Veeramootoo 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. — View Citation

Watson YI, Arfken CL, Birge SJ. Clock completion: an objective screening test for dementia. J Am Geriatr Soc. 1993 Nov;41(11):1235-40. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	feasibility of the online-based sports program	analysis by written questionnaire	6 months
Primary	peak oxygen uptake (VO2peak)	First measurement three months prior to surgery (baseline), Second measurement immediately before surgery, third measurement three months after esophagectomy	6 months
Secondary	Gastric conduit failure after esophagectomy	(type classification according to Veeramootoo et al. (2009)) Evaluation of postoperative in-hospital stay	intraoperative
Secondary	pneumonia	Evaluation of postoperative in-hospital stay	intraoperative
Secondary	duration of mechanical ventilation	Evaluation of postoperative in-hospital stay	intraoperative
Secondary	re-intubation rate	Evaluation of postoperative in-hospital stay	intraoperative
Secondary	Duration of intensive care unit stay	Evaluation of postoperative in-hospital stay	intraoperative
Secondary	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	6 months