Clinical trial · Interventional
Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS)
Evaluation of a Multimodal Program of Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery Within an ERAS Pathway.
- 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)
The importance of postoperative rehabilitation on physical performance and recovery is well-recognized. However, the preoperative period constitutes a unique opportunity to address comorbidities and modifiable risk factors, improve functional capacity and address deficiencies in physiologic reserve, which might otherwise preclude surgery or significantly impede recovery. Therefore, the aim of this study is to evaluate the efficacy of a multimodal program of prehabilitation in patients undergoing major oncological gastrointestinal surgery. The hypothesis is that severe post-operative complications within 30 days will be reduced in the treatment group compared to the control group.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Major Surgery | — | UNRESOLVED | — |
| Oncological Patients | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal prehabilitation Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prehabilitation
- description
- Prehabilitation arm group will receive preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline.
- interventionNames
- Behavioral: Multimodal prehabilitation Program
- type
- NO_INTERVENTION
- label
- Control group
- description
- Standard care treatment. Application of ERAS pathways (Enhanced Recovery After Surgery)
Primary outcomes (1)
- measure
- Postoperative complications
- timeFrame
- Evaluation of severe post-operative complications within 30 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All adult patients (age \> 18 years) scheduled for elective gastrointestinal surgery for cancer. * Signed informed consent Exclusion Criteria: Co-morbid medical, physical, and mental conditions interfering with the ability to complete study procedures, such as: * acute or unstable cardio-respiratory conditions (e.g., unstable angina or symptomatic severe aortic stenosis) * severe/end-stage organ diseases (e.g., cardiac failure NYHA functional classes III-IV, COPD FEV1 \<50% pred, end-stage kidney or liver disease); * American Society of Anesthesiologists (ASA) physical status classes 4-5. * disabling orthopedic and neuromuscular disease. * psychosis, dementia; * symptomatic anemia. * Pregnancy
References
Publications (21)
- BACKGROUNDDesborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available. PMID 10927999
- BACKGROUNDBautmans I, Njemini R, De Backer J, De Waele E, Mets T. Surgery-induced inflammation in relation to age, muscle endurance, and self-perceived fatigue. J Gerontol A Biol Sci Med Sci. 2010 Mar;65(3):266-73. doi: 10.1093/gerona/glp145. Epub 2009 Oct 6. PMID 19808837
- BACKGROUNDCarli F. Physiologic considerations of Enhanced Recovery After Surgery (ERAS) programs: implications of the stress response. Can J Anaesth. 2015 Feb;62(2):110-9. doi: 10.1007/s12630-014-0264-0. Epub 2014 Dec 12. PMID 25501695
- BACKGROUNDLemanne D, Cassileth B, Gubili J. The role of physical activity in cancer prevention, treatment, recovery, and survivorship. Oncology (Williston Park). 2013 Jun;27(6):580-5. PMID 23909073
- BACKGROUNDArends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6. PMID 27637832
- BACKGROUNDShen Y, Hao Q, Zhou J, Dong B. The impact of frailty and sarcopenia on postoperative outcomes in older patients undergoing gastrectomy surgery: a systematic review and meta-analysis. BMC Geriatr. 2017 Aug 21;17(1):188. doi: 10.1186/s12877-017-0569-2. PMID 28826406
- BACKGROUNDJack S, West MA, Raw D, Marwood S, Ambler G, Cope TM, Shrotri M, Sturgess RP, Calverley PM, Ottensmeier CH, Grocott MP. The effect of neoadjuvant chemotherapy on physical fitness and survival in patients undergoing oesophagogastric cancer surgery. Eur J Surg Oncol. 2014 Oct;40(10):1313-20. doi: 10.1016/j.ejso.2014.03.010. Epub 2014 Mar 27.