Improving Outcomes in Patients With Hepatobiliary Cancers With a Nutritional and Physical Conditioning Pre-habilitation Program
18 Years
80 Years
Both
Colorectal Neoplasm, Biliary Tract Neoplasm, Liver Neoplasm
Trial Information
Improving Outcomes in Patients With Hepatobiliary Cancers With a Nutritional and Physical Conditioning Pre-habilitation Program
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Change in six minute walk test
Outcome Description:
The primary outcome is patient-relevant, functional walking capacity as measured by the six-minute walk test (6MWT). The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living
Outcome Time Frame:
8 weeks pre-op and 1 week pre-op
Safety Issue:
No
Principal Investigator
Prosanto Chaudhury, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
McGill University Health Center
Authority:
Canada: Health Canada
Study ID:
BMA-10-375
NCT ID:
NCT01542281
Start Date:
January 2012
Completion Date:
January 2015
Related Keywords:
- Colorectal Neoplasm
- Biliary Tract Neoplasm
- Liver Neoplasm
- liver resection
- hepatectomy
- pre-habilitation
- Biliary Tract Neoplasms
- Neoplasms
- Colorectal Neoplasms
- Liver Neoplasms
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