Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases

Not Applicable

Recruiting

• Conditions: Neoadjuvant Therapy; Liver Metastases; Prehabilitation

• Registration Number: NCT04520737
• Lead Sponsor: Institut Investigacio Sanitaria Pere Virgili

Brief Summary

Liver resection is the only curative treatment for patients with colorectal liver metastases (CRLM). Most patients undergo chemotherapy (CT) before liver surgery. CT objectively decreases patient functional capacity. It has already been demonstrated that a structured training program carried out during the 4 weeks following CT, while the patient is waiting for liver resection, is able to return the functional capacity to baseline levels. Despite this, multimodal prehabilitation programs (MPP) during preoperative CT have not been evaluated or implemented.

The aim of this study is to investigate whether a 16-week MPP applied during and following CT in CRLM patients will result in a significant increase in physical fitness when compared to those that undergo MPP only during the 4-weeks, between the end of CT and liver resection.

Detailed Description

The primary aim of the study is to evaluate the effectiveness of a multimodal prehabilitation program (MPP) in CRLM patients, which will be implemented right through the period of preoperative CT and during the 4-weeks of recovery before liver resection.

MPP will consist of in-hospital high-moderate intensive exercise training, nutritional assessment and high-protein supplementation, smoking cessation, psychological support and Comprehensive Geriatric Assessment.

Expected improvement in physical fitness will be measured by the difference in meters achieved in the six-minute walk test (6MWT) and will be compared with patients that will follow the MPP only during the 4-weeks before surgery, when preoperative CT has been finished.

Secondary aims include patient reported outcomes measures such as quality of life, postoperative complications, length of hospital stay, 30-day mortality and re-admissions. Protocol feasibility will be evaluated by monitoring all interventions.

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-18
• Study First Posted: 2020-08-20
• Study Start: 2021-02-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-07-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Age ≥ 18 years
• Written informed consent obtained from subject to participate in the study.

Exclusion Criteria

• Age <18 years
• ASA health class status IV-V
• Mental conditions or disabling orthopedic and neuromuscular disease that prevent physical exercise or may compromise adherence to the program
• Medical contraindication to perform exercise
• Inability to obtain informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical Fitness- 6MWT	Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative	Change in physical fitness will be measured by the six-minute walk test (6MWT). This test measures the distance an individual can walk, in metres, in a 6-minute period. Greater distance walked during the 6MWT indicates greater functional capacity.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications- Clavien-Dindo classification	Through study completion, up to one year postoperative	The Clavien-Dindo classification consists of 7 grades. Grade I: any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions; Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications; Grade III (IIIa, IIIb): Requiring surgical, endoscopic or radiological intervention; Grade IV (Iva, IVb): Life-threatening complication requiring IC/ICU management; Grade V: death of the patient.
Readmissions rate	Postoperative period: Up to 30 postoperative days	Rate of un-planned hospital readmissions within 30 days of discharge after hospitalization.
Functional capacity- Handgrip strength	Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative	It will be measured using an hydraulic hand dynamometer. Three measures from each hand will be taken, with patient seated and arm bent at a 90-degree angle. The average of the three measures for each hand will be recorded.
Postoperative complications- CCI	Through study completion, up to one year postoperative	The Comprehensive Complication Index (CCI) integrates in a single formula all complications by severity, ranging from 0 (uneventful course) to 100 (death).
Nutritional status- BIA	Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative	The Bio-electrical Impedance Analysis (BIA) is a method to determine body composition. The measurement of body fat in relation to lean body mass.
Postoperative hospital length of stay	Postoperative period: assessed up to the first year postoperative	The patient's postoperative length of stay will be recorded from the medical records. It will be calculated from the date of surgery until to the date of discharge from the hospital. It will be reported in days.
Functional capacity- 30CST	Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative	The 30-second sit to stand test (30CST) measures lower body strength by recording the maximum number of times an individual can go from a seated position to a standing position, without using their arms, in a 30-second period.
Health-related quality of life- SF-36	Baseline (before chemotherapy), week 16 (before surgery), 8 weeks postoperative, 1 year postoperative	Quality of life will be evaluated by using the SF-36 mental health score. This survey measures eight scales of health: physical function, role physical, role emotional, social functioning, bodily pain, general health, vitality, and mental health. Each items are scored on a 0 to 100 range. A high score defines a more favorable health state.
Nutritional status- PG-SGA	Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative	The Patient-Generated Subjective Global Assessment (PG-SGA) is a validated questionnaire used to assess the nutritional and functional status of cancer patients. The scoring system allows patients at risk for malnutrition to be identified and triaged for nutritional intervention. A score ≥9 indicates a critical need for nutritional intervention.
Nutritional status- UMA	Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative	Upper-arm muscle area (UMA) is the circumference of the left upper arm, measured at the mid-point between the tip of the shoulder and the tip of the elbow.
Psychological health- HADS	Baseline (before chemotherapy), week 16 (before surgery), 8 weeks postoperative, 1 year postoperative	Emotional health will be measured using the Hospital Anxiety and Depression Scale (HADS). The HADS contains seven items, each scored from 0 to 3 points for anxiety and depression. It provides summary measures on a scale of 0-21, with scores exceeding 8 suggesting the presence of a mood disorder
Nutritional status- BMI	Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative	Body Mass Index (BMI) is weight in kilograms divided by height in meters squared.

Trial Locations

Locations (1)

Hospital Universitari de Tarragona Joan XXIII; 🇪🇸 Tarragona, Spain