Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases

NCT04520737 | Recruiting DMC

• 1 other identifier: PREHABMET
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Prehabilitation; Neoadjuvant Therapy; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• Physical Fitness- 6MWT

  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.

  Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative

Secondary Outcomes (12)

• Postoperative complications- Clavien-Dindo classification

  Through study completion, up to one year postoperative

• Postoperative complications- CCI

  Through study completion, up to one year postoperative

• Postoperative hospital length of stay

  Postoperative period: assessed up to the first year postoperative

• Readmissions rate

  Postoperative period: Up to 30 postoperative 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

Study Arms (2)

16W group

ACTIVE COMPARATOR

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

Behavioral: Physical Prehabilitation

4W group

ACTIVE COMPARATOR

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

Behavioral: Physical Prehabilitation

Interventions

Physical Prehabilitation 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.

Also known as: Nutritional intervention, Psychological intervention, Smoking cessation, Comprehensive Geriatric Assessment (CGA) and co-morbidity assessment

16W group; 4W group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead

Study Sites (1)

Hospital Universitari de Tarragona Joan XXIII

Tarragona, 43005, Spain

RECRUITING

MeSH Terms

Interventions

Psychosocial Intervention; Geriatric Assessment

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Laia Estalella, PhD

  Hospital Universitari de Tarragona Joan XXIII

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laia Estalella, PhD

CONTACT

+34 628164461; laiaestalella2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The participant will be randomized (1:1) using seed, a Stata's random-number generated function. The subjects will be allocated into one of the two groups of the study.

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 20, 2020
• Study Start: February 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)