Clinical trial NCT01542281: Pre-habilitation to Improve Outcomes in Patients Undergoing Liver Resection for Cancer
Official title: Improving Outcomes in Patients With Hepatobiliary Cancers With a Nutritional and Physical Conditioning Pre-habilitation Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasm
Biliary Tract Neoplasm
Liver Neoplasm
Keywords: liver resection
hepatectomy
pre-habilitation
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in six minute walk test
timeFrame: 8 weeks pre-op and 1 week pre-op
Secondary outcomes:
measure: post-operative complications
timeFrame: 30 days
measure: Health-related quality of life (HRQL)
timeFrame: 8 and 1 week pre-operatively, 4 and 8 weeks post-operatively
measure: Physical activity level
timeFrame: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively
measure: Depression and anxiety
timeFrame: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively
measure: Fatigue
timeFrame: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively
measure: Nutritional status
timeFrame: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Prosanto Chaudhury, MD
role: PRINCIPAL_INVESTIGATOR
References: