Actively Recruiting
Multimodal Prehabilitation During Neoadjuvant Chemotherapy in Patients With Colorectal Liver Metastases: a Randomized Controlled Trial
Led by Institut Investigacio Sanitaria Pere Virgili · Updated on 2024-07-01
84
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with colorectal liver metastases (CRLM) to see if a 16-week multimodal prehabilitation program (MPP) given during chemotherapy and recovery before liver surgery can improve physical fitness more than a 4-week program given only after chemotherapy. Liver resection is the only curative option for CRLM, but chemotherapy reduces physical capacity. This study aims to find better ways to help patients regain fitness before surgery through a structured program. The MPP includes in-hospital high to moderate intensity exercise, nutrition assessment with high-protein supplements, smoking cessation support, psychological help, and a comprehensive geriatric assessment. Two groups will be compared: one receiving the program during 12 weeks of chemotherapy plus 4 weeks before surgery, and another starting the program only in the 4 weeks after chemotherapy until surgery. Participants will be assessed using the six-minute walk test (6MWT) at several points including before chemotherapy, after chemotherapy, before surgery, and postoperatively up to one year. Other measures include quality of life, postoperative complications, hospital stay length, readmission rates, functional capacity tests, psychological health, and nutritional status. The study will monitor all interventions to check feasibility and safety throughout the trial period ending one year after surgery.
CONDITIONS
Brief Title
Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 218 years
- Written informed consent obtained from subject to participate in the study.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 to 16 weeks depending on group assignment
Participants undergo a multimodal prehabilitation program including high-moderate intensive exercise training, nutritional assessment with high-protein supplementation, smoking cessation, psychological support, and Comprehensive Geriatric Assessment during chemotherapy and/or the preoperative period.
Visits during chemotherapy and preoperative period as scheduled by the program
Duration - Up to 1 year postoperative
Participants are monitored for recovery and outcomes including physical fitness, functional capacity, nutritional status, psychological health, postoperative complications, and hospital readmissions.
Follow-up visits at 4 weeks, 8 weeks, and 1 year after surgery
Trial Site Locations
Total: 1 location
1
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Spain, 43005
Actively Recruiting
Research Team
L
Laia Estalella, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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