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

NCT ID: NCT01542281

Last Updated: 2012-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-01-31

Brief 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.

Detailed 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.

Conditions

Colorectal Neoplasm; Biliary Tract Neoplasm; Liver Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Nutritional supplementation and prehab

The first group (pre-hab) will receive both nutritional supplementation and a prehabilitation program.

Group Type: EXPERIMENTAL

Whey protein and dietary supplements

Intervention Type: DIETARY_SUPPLEMENT

Whey protein and dietary supplements in addition to pre-hab exercise

Prehab exercise

Group Type: ACTIVE_COMPARATOR

prehab exercise

Intervention Type: OTHER

minimum 4 weeks and maximum 8 weeks; 3 times a week

Interventions

Whey protein and dietary supplements

Whey protein and dietary supplements in addition to pre-hab exercise

Intervention Type: DIETARY_SUPPLEMENT

prehab exercise

minimum 4 weeks and maximum 8 weeks; 3 times a week

Intervention Type: OTHER

Other Intervention Names

weight training , walking, cycling etc.

Eligibility Criteria

Inclusion Criteria

• Subjects eligible to enter the prehabilitation program will include those aged 18 and above and referred electively for resection of malignancies.

Exclusion Criteria

• Excluded will be persons with American Society of Anesthesiologists (ASA) health status class 4-5 or co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis), cardiac abnormalities, severe end-organ disease such as cardiac failure, COPD, and hepatic failure (ALT and AST >50% over the normal range), and sepsis), morbid obesity (BMI >40), anemia (hematocrit < 30 %) and other conditions interfering with the ability to perform exercise at home or to complete the testing procedures.
• Patients will be excluded if they have poor English or French comprehension.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Prosanto Chaudhury

HPB and Transplant Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prosanto Chaudhury, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ayat Salman, MSccandidate

Role: CONTACT

ayat.salman@muhc.mcgill.ca

5149341934 ext. 36237

Facility Contacts

Ayat Salman, MSccandidate

Role: primary

ayat.salman@muhc.mcgill.ca

5149341934 ext. 36237

Other Identifiers

BMA-10-375

Identifier Type: -

Identifier Source: org_study_id