Multimodal Prehabilitation in Colorectal Cancer Patients

Status Recruiting

Clinical Trial Summary

Postoperative complications can occur in up to 50% of individuals undergoing colorectal resection and are associated with poor prognosis, increased costs, and lower health-related quality of life. Even in the absence of complications, after major surgery, patients reduce their physiological and functional capacity by 20-40% and show a higher level of fatigue for 6-8 weeks. Many of these negative effects can be decreased by applying specific ERAS (Enhanced Recovery After Surgery) programs which, by attenuating the neuro-endocrine response induced by surgical trauma, accelerate patients' post-operative convalescence and facilitate their return to functional activities. In this study, the research group hypothesizes that a prehabilitation program based on physical exercise, nutritional optimization and psychological support (trimodal) carried out by patients in the 4 weeks before elective colorectal resection surgery can determine: 1) better physical performance 8 weeks after surgery (measured by the 6-minute walk test), 2) a possible decrease in postoperative complications, and 3) a reduction in in-hospital (direct) and post-hospital discharge (indirect) costs.

Clinical Trial Description

This study aims to determine the effect of prehabilitation on patients' functional capacity and postoperative complications. It is a randomized trial including 112 patients undergoing colorectal surgery for cancer. Patients will be allocated to intervention group receiving 4 weeks trimodal prehabilitation (N=56) or control group receiving no prehabilitation (N=56). After surgery, both groups will follow 8 weeks rehabilitation based on Enhanced Recovery After Surgery (ERAS) guidelines. The primary endpoint is functional capacity, secondary outcomes include postoperative complications and a cost-effectiveness analysis. Multimodal prehabilitation is expected to increase functional capacity and lower postoperative complications. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06443203
Study type	Interventional
Source	University Hospital of Ferrara
Contact	CARLO CF FEO, MD FACS
Phone	+39 3282198106
Email	fcl@unife.it
Status	Recruiting
Phase	N/A
Start date	June 15, 2021
Completion date	September 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05551052` - CRC Detection Reliable Assessment With Blood
Completed	`NCT03457454` - Reducing Rural Colon Cancer Disparities
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Active, not recruiting	`NCT04088955` - A Digimed Oncology PharmacoTherapy Registry
Recruiting	`NCT06010862` - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors	Phase 1
Terminated	`NCT01347645` - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer	Phase 1/Phase 2
Completed	`NCT03390907` - Hybrid APC Assisted EMR for Large Colon Polyps	N/A
Recruiting	`NCT03175224` - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors	Phase 2
Completed	`NCT04079478` - The AID Study: Artificial Intelligence for Colorectal Adenoma Detection
Active, not recruiting	`NCT04057274` - Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth	N/A
Recruiting	`NCT03190941` - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients	Phase 1/Phase 2
Not yet recruiting	`NCT05147545` - Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects	N/A
Recruiting	`NCT05026268` - The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis	N/A
Not yet recruiting	`NCT03277235` - Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients	N/A
Active, not recruiting	`NCT02730702` - Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
Active, not recruiting	`NCT02959541` - PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer	N/A
Completed	`NCT02810652` - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection	N/A
Recruiting	`NCT02577627` - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC	N/A
Terminated	`NCT02628535` - Safety Study of MGD009 in B7-H3-expressing Tumors	Phase 1
Recruiting	`NCT02526836` - Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer	Phase 2/Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.