Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04520737
Study type	Interventional
Source	Institut Investigacio Sanitaria Pere Virgili
Contact	Laia Estalella, PhD
Phone	+34 628164461
Email	laiaestalella2@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	September 2020
Completion date	September 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03781934` - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations	Phase 1/Phase 2
Completed	`NCT02107755` - Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma	Phase 2
Recruiting	`NCT05057052` - Cryoablation Combined With Sintilimab Plus Regorafenib In Previously Treated Colorectal Cancer Liver Metastasis	Phase 2
Recruiting	`NCT06120127` - Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence	Phase 2
Recruiting	`NCT04837885` - Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases	Phase 2
Terminated	`NCT04589884` - Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
Terminated	`NCT02465112` - Metabolic Radiotherapy After Complete Resection of Liver Metastases in Patient With Digestive Neuroendocrine Tumor	Phase 3
Completed	`NCT02352259` - Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II	Phase 2
Active, not recruiting	`NCT01763450` - Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer	Phase 2
Withdrawn	`NCT01631539` - Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC	N/A
Recruiting	`NCT01250158` - Liver-PILP First-in-Man	N/A
Terminated	`NCT01233544` - Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases	Phase 3
Completed	`NCT01347333` - Stereotactic Body Radiotherapy for Liver Tumors	N/A
Completed	`NCT01683357` - Prognosis of One-stage Hepatectomy for Bilobar Colorectal Metastases	N/A
Completed	`NCT00587756` - Alternative to Two-Stage Hepatectomy	N/A
Completed	`NCT04942665` - Low Dose ICG for Biliary Tract and Tumor Imaging	Phase 2
Not yet recruiting	`NCT05354674` - Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
Recruiting	`NCT04616495` - Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
Not yet recruiting	`NCT04509635` - Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis	Phase 3
Recruiting	`NCT04178759` - Impact of Chemotherapy and Regenerative Markers of Liver Regeneration After Liver Resection for Liver Metastases	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases — PREHABMET

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms