Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases

NCT ID: NCT04520737

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2026-12-31

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.

Conditions

Prehabilitation; Neoadjuvant Therapy; Liver Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

16W group

Multimodal prehabilitation program (MPP) will be implemented during 16 weeks, 12 weeks during chemotherapy (CT) and 4 weeks while waiting for surgery.

Group Type: ACTIVE_COMPARATOR

Physical Prehabilitation

Intervention Type: BEHAVIORAL

The prehabilitation program consists of the following interventions: in-hospital high-moderate intensive exercise training, nutritional assessment and high-protein supplementation, smoking cessation, psychological support and Comprehensive Geriatric Assessment.

4W group

Multimodal prehabilitation program (MPP) will start at the end of preoperative chemotherapy (CT) until surgery (4 weeks in total).

Group Type: ACTIVE_COMPARATOR

Physical Prehabilitation

Intervention Type: BEHAVIORAL

The prehabilitation program consists of the following interventions: in-hospital high-moderate intensive exercise training, nutritional assessment and high-protein supplementation, smoking cessation, psychological support and Comprehensive Geriatric Assessment.

Interventions

Physical Prehabilitation

The prehabilitation program consists of the following interventions: in-hospital high-moderate intensive exercise training, nutritional assessment and high-protein supplementation, smoking cessation, psychological support and Comprehensive Geriatric Assessment.

Intervention Type: BEHAVIORAL

Other Intervention Names

Nutritional intervention; Psychological intervention; Smoking cessation; Comprehensive Geriatric Assessment (CGA) and co-morbidity assessment

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Investigacio Sanitaria Pere Virgili

OTHER

Sponsor Role: lead

Responsible Party

Laia Estalella Mercade

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laia Estalella, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari de Tarragona Joan XXIII

Locations

Hospital Universitari de Tarragona Joan XXIII

Tarragona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Laia Estalella, PhD

Role: CONTACT

laiaestalella2@gmail.com

+34 628164461

Facility Contacts

Laia Estalella, PhD

Role: primary

laiaestalella2@gmail.com

+34 628164461

Other Identifiers

PREHABMET

Identifier Type: -

Identifier Source: org_study_id