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Clinical Trials in Spain / NCT04520737
Recruiting Not applicable

Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases

NCT04520737 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2021-02-01
Last updated
2024-07-01

Condition(s) studied

PrehabilitationNeoadjuvant TherapyLiver Metastases

Investigational drug(s) / intervention(s)

Physical Prehabilitation

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitari de Tarragona Joan XXIII Tarragona Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04520737 on ClinicalTrials.gov ↗ ← All trials in Spain