Pre-habilitation to Improve Outcomes in Patients Undergoing Liver Resection for Cancer

Colorectal Neoplasm Clinical Trial

Official title: Improving Outcomes in Patients With Hepatobiliary Cancers With a Nutritional and Physical Conditioning Pre-habilitation Program

Status Recruiting

Clinical Trial Summary

1. To determine whether a combined nutritional support program and exercise-based prehabilitation is superior to nutritional support alone in increasing functional recovery and reducing post-operative morbidity after surgery for HPB malignancy.

2. To understand which measures of immediate surgical recovery are sensitive to prehabilitation interventions and predict change in later outcome measures.

Clinical Trial Description

Patients scheduled for elective liver resection be will be approached andrandomized to one of two groups using a computer generated block randomisation scheme. The first group (pre-hab) will receive both nutritional supplementation and a prehabilitation program as outlined below. The second group (nutrition) will receive only nutritional supplementation. Both groups will be given a post-operative exercise program.

Once randomized, the subjects will be called by the research co-ordinator and an appointment will be made for the initial assessment. After the study is explained and consent obtained, subjects will be tested on 6MWT, followed by a 30 minute rest period during which various questionnaires assessing physical activity, quality of life, fatigue and nutritional status will be completed with the aid of the coordinator.

The prehabilitation program will last a minimum of four weeks and a maximum of 8 weeks.

Surgery will be performed by one of the HPB surgeons at the McGill University Health Center. Surgical approach, including laparoscopic or open surgery will be at the discretion of the surgeon. Perioperative care will follow an Enhanced Recovery After Surgery (ERAS)-based clinical care pathway27, 28, a fast-track care plan including patient education, afferent neural blockade, multimodal analgesia, early oral intake and mobilization, early removal of catheters and drains, and a planned 6-8 day hospital admission. This pathway has already been implemented at the Royal Victoria Hospital as part of standard patient care. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Biliary Tract Neoplasm
• Biliary Tract Neoplasms
• Colorectal Neoplasm
• Colorectal Neoplasms
• Liver Neoplasm
• Liver Neoplasms
• Neoplasms

• NCT number: NCT01542281
• Study type: Interventional
• Source: McGill University Health Center
• Contact: Ayat Salman, MSccandidate
• Phone: 5149341934
• Email: ayat.salman@muhc.mcgill.ca
• Status: Recruiting
• Phase: N/A
• Start date: January 2012
• Completion date: January 2015