Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases (PREHABMET)

June 27, 2024 updated by: Laia Estalella Mercade, Institut Investigacio Sanitaria Pere Virgili

Multimodal Prehabilitation During Neoadjuvant Chemotherapy in Patients With Colorectal Liver Metastases: a Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Tarragona, Spain, 43005
        • Recruiting
        • Hospital Universitari de Tarragona Joan XXIII
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 16W group
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
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.
Other Names:
  • Nutritional intervention
  • Psychological intervention
  • Smoking cessation
  • Comprehensive Geriatric Assessment (CGA) and co-morbidity assessment
Active Comparator: 4W group
Multimodal prehabilitation program (MPP) will start at the end of preoperative chemotherapy (CT) until surgery (4 weeks in total).
Behavioral: 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.
Other Names:
  • Nutritional intervention
  • Psychological intervention
  • Smoking cessation
  • Comprehensive Geriatric Assessment (CGA) and co-morbidity assessment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical Fitness- 6MWT
Time Frame: 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.
Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative complications- Clavien-Dindo classification
Time Frame: 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.
Through study completion, up to one year postoperative
Postoperative complications- CCI
Time Frame: 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).
Through study completion, up to one year postoperative
Postoperative hospital length of stay
Time Frame: 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.
Postoperative period: assessed up to the first year postoperative
Readmissions rate
Time Frame: Postoperative period: Up to 30 postoperative days
Rate of un-planned hospital readmissions within 30 days of discharge after hospitalization.
Postoperative period: Up to 30 postoperative days
Functional capacity- 30CST
Time Frame: 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.
Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Health-related quality of life- SF-36
Time Frame: 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.
Baseline (before chemotherapy), week 16 (before surgery), 8 weeks postoperative, 1 year postoperative
Psychological health- HADS
Time Frame: 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
Baseline (before chemotherapy), week 16 (before surgery), 8 weeks postoperative, 1 year postoperative
Functional capacity- Handgrip strength
Time Frame: 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.
Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Nutritional status- PG-SGA
Time Frame: 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.
Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Nutritional status- BMI
Time Frame: 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.
Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Nutritional status- BIA
Time Frame: 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.
Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative
Nutritional status- UMA
Time Frame: 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.
Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Investigacio Sanitaria Pere Virgili

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laia Estalella, PhD, Hospital Universitari de Tarragona Joan XXIII

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PREHABMET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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