Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery (PROGRESS)

Major Surgery Clinical Trial

— PROGRESS  

Official title:

Evaluation of a Multimodal Program of Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery Within an ERAS Pathway.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06404489
• Other study ID #: PROGRESS - CET 191-2023
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2024
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: Università Vita-Salute San Raffaele
• Contact: Luigi Beretta, Prof
• Phone: +39022643
• Email: beretta.luigi[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Major Surgery

Intervention

Behavioral:
• Multimodal prehabilitation Program
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. The duration of program will be set at 4 weeks. All activities will be performed in dedicated suites at each site, under supervision of qualified health professionals.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria	Cagliari	Sardegna
Italy	IRCCS San Raffaele Scientific Institute	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (20)

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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. — View Citation

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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. — View 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. — View 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. — View Citation

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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. — View 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. — View 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. — View Citation

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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. — View 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. — View 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. — View 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. — View Citation

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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. — View 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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Reduction of incidence of postoperative complications.	Evaluation of severe post-operative complications within 30 days
Secondary	Lenght of hospital stay	Reduction of lenght of hospital stay in treatment group	30 days after surgery
Secondary	Proportion of patients returning to preoperative functional walking capacity	Improving return to basal functional preoperative capacity	30 days after surgery, 90 days follow up after surgery