Clinical trial NCT06404489: Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS)
Official title: Evaluation of a Multimodal Program of Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery Within an ERAS Pathway.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oncological Patients
Major Surgery
Keywords: Prehabilitation
Multimodal prehabilitation program
Standard care treatment
Major gastrointestinal surgery
Hospital stay
Functional walking
Nutrition
Diet
Exercise
Relaxation
Oncology
Functional recovery
Anesthesiology
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: This is a 2-arm randomized multicentric controlled trial to test the efficacy of a personalized, multidisciplinary, preoperative conditioning program to reduce severe complications and facilitate recovery in patients undergoing major oncological gastrointestinal surgery.

400 patients will be randomized (ratio 1:1) and allocated either to the intervention group (Prehabilitation), or to the control group (which will be treated according to usual standard of care within Enhanced Recovery After Surgery (ERAS) pathways).

Multimodal prehabilitation is a preoperative intervention which includes exercise training, nutritional therapy and anxiety reducing techniques, aimed at preventing or attenuating surgery-driven functional decline.

The primary objective is to evaluate the effect of a multimodal program of prehabilitation on postoperative severe complications.

Secondary outcomes include time to functional recovery, length of hospital stay, complication severity, proportion of patients returning to preoperative functional walking capacity and self-reported activity status and generic health related quality of life at 30 days after surgery.

Included patients will be randomized and allocated either to the intervention group, which will receive 4 weeks of prehabilitation, or to the control group, which will receive no prehabilitation. All patients will be reassessed the day before surgery, 30 days and 3 months after surgery.

Patients enrolled in treatment group will not receive any additional medication but only a multimodal program to optimize their preoperative functional capacity.

Within 30 days prior to scheduled surgery, participants of both groups will undergo a specialized multidisciplinary assessment with a physician, a certified physiotherapist, registered dietitian and psychology trained personnel. All tests will be performed following international guidelines and standardized verbal instructions. A tailored intervention will be prescribed if specific physical, nutritional or psychological impairments will be identified during the assessment phase. Based on the data obtained during the multimodal assessment, different domains and levels of care will be prescribed, focusing on exercise training, and/or nutrition optimization, and/or distress-coping techniques. Different combinations of three domains will be utilized to maximize their synergistic anabolic effect.

Statistical analysis will be performed according to study sites, type of surgery (esophageal, gastric, colonic, rectal) and neoadjuvant treatment.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative complications
timeFrame: Evaluation of severe post-operative complications within 30 days
Secondary outcomes:
measure: Lenght of hospital stay
timeFrame: 30 days after surgery
measure: Proportion of patients returning to preoperative functional walking capacity
timeFrame: 30 days after surgery, 90 days follow up after surgery
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Azienda Ospedaliera Universitaria
state: Sardegna
city: Milan
country: Italy
facility: IRCCS San Raffaele Scientific Institute
Study officials:
References:
citation: Desborough 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.
citation: Bautmans 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.
citation: Carli 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.
citation: Lemanne 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.
citation: Arends 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.
citation: Shen 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.
citation: Jack 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.
citation: Carlsson E, Berndtsson I, Hallen AM, Lindholm E, Persson E. Concerns and quality of life before surgery and during the recovery period in patients with rectal cancer and an ostomy. J Wound Ostomy Continence Nurs. 2010 Nov-Dec;37(6):654-61. doi: 10.1097/WON.0b013e3181f90f0c.
citation: Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe.
citation: Wijeysundera DN, Pearse RM, Shulman MA, Abbott TEF, Torres E, Ambosta A, Croal BL, Granton JT, Thorpe KE, Grocott MPW, Farrington C, Myles PS, Cuthbertson BH; METS study investigators. Assessment of functional capacity before major non-cardiac surgery: an international, prospective cohort study. Lancet. 2018 Jun 30;391(10140):2631-2640. doi: 10.1016/S0140-6736(18)31131-0.
citation: Pecorelli N, Fiore JF Jr, Gillis C, Awasthi R, Mappin-Kasirer B, Niculiseanu P, Fried GM, Carli F, Feldman LS. The six-minute walk test as a measure of postoperative recovery after colorectal resection: further examination of its measurement properties. Surg Endosc. 2016 Jun;30(6):2199-206. doi: 10.1007/s00464-015-4478-1. Epub 2015 Aug 27.
citation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
citation: Boshier PR, Heneghan R, Markar SR, Baracos VE, Low DE. Assessment of body composition and sarcopenia in patients with esophageal cancer: a systematic review and meta-analysis. Dis Esophagus. 2018 Aug 1;31(8). doi: 10.1093/dote/doy047.
citation: Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85. doi: 10.1038/sj.ejcn.1601412.
citation: Levett DZH, Jack S, Swart M, Carlisle J, Wilson J, Snowden C, Riley M, Danjoux G, Ward SA, Older P, Grocott MPW; Perioperative Exercise Testing and Training Society (POETTS). Perioperative cardiopulmonary exercise testing (CPET): consensus clinical guidelines on indications, organization, conduct, and physiological interpretation. Br J Anaesth. 2018 Mar;120(3):484-500. doi: 10.1016/j.bja.2017.10.020. Epub 2017 Nov 24.
citation: Zopfs D, Theurich S, Grosse Hokamp N, Knuever J, Gerecht L, Borggrefe J, Schlaak M, Pinto Dos Santos D. Single-slice CT measurements allow for accurate assessment of sarcopenia and body composition. Eur Radiol. 2020 Mar;30(3):1701-1708. doi: 10.1007/s00330-019-06526-9. Epub 2019 Nov 27.
citation: Carli F, Gillis C, Scheede-Bergdahl C. Promoting a culture of prehabilitation for the surgical cancer patient. Acta Oncol. 2017 Feb;56(2):128-133. doi: 10.1080/0284186X.2016.1266081. Epub 2017 Jan 9.
citation: Colado JC, Pedrosa FM, Juesas A, Gargallo P, Carrasco JJ, Flandez J, Chupel MU, Teixeira AM, Naclerio F. Concurrent validation of the OMNI-Resistance Exercise Scale of perceived exertion with elastic bands in the elderly. Exp Gerontol. 2018 Mar;103:11-16. doi: 10.1016/j.exger.2017.12.009. Epub 2017 Dec 17.
citation: Babic B, Tagkalos E, Gockel I, Corvinus F, Hadzijusufovic E, Hoppe-Lotichius M, Lang H, van der Sluis PC, Grimminger PP. C-reactive Protein Levels After Esophagectomy Are Associated With Increased Surgical Trauma and Complications. Ann Thorac Surg. 2020 May;109(5):1574-1583. doi: 10.1016/j.athoracsur.2019.12.016. Epub 2020 Jan 24.
citation: Schulz SVW, Schumann U, Otto S, Kirsten J, Treff G, Janni W, Huober J, Leinert E, Steinacker JM, Bizjak DA. Two-year follow-up after a six-week high-intensity training intervention study with breast cancer patients: physiological, psychological and immunological differences. Disabil Rehabil. 2022 Aug;44(17):4813-4820. doi: 10.1080/09638288.2021.1921861. Epub 2021 May 11.