Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Investigacio Sanitaria Pere Virgili
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Written informed consent obtained from subject to participate in the study.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Physical Prehabilitation
BehavioralThe 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: 16W groupActive comparator 1 intervention
Group B: 4W groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (before chemotherapy), week 12 (end of chemotherapy), week 16 (before surgery), 4 weeks postoperative, 8 weeks postoperative, 1 year postoperativeSecondary outcomes
1
Postoperative complications- Clavien-Dindo classification
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.
Time frame
Through study completion, up to one year postoperative2
Postoperative complications- CCI
The Comprehensive Complication Index (CCI) integrates in a single formula all complications by severity, ranging from 0 (uneventful course) to 100 (death).
Time frame
Through study completion, up to one year postoperative3
Postoperative hospital length of stay
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.
Time frame
Postoperative period: assessed up to the first year postoperative4
Readmissions rate
Rate of un-planned hospital readmissions within 30 days of discharge after hospitalization.
Time frame
Postoperative period: Up to 30 postoperative daysSponsors and contacts
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Source ClinicalTrials.gov