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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Neoplasm; Liver Neoplasm; Biliary Tract Neoplasm
• Intervention / Treatment: Dietary supplement: Whey protein and dietary supplements; Other: prehab exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A1A1
      • Recruiting
      • Royal Victoria Hospital
      • Contact: Ayat Salman, MSccandidate; Phone Number: 36237 5149341934; Email: ayat.salman@muhc.mcgill.ca
      • Principal Investigator: Prosanto Chaudhury, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional supplementation and prehab; The first group (pre-hab) will receive both nutritional supplementation and a prehabilitation program.	Dietary supplement: Whey protein and dietary supplements; Whey protein and dietary supplements in addition to pre-hab exercise
Active Comparator: Prehab exercise	Other: prehab exercise; minimum 4 weeks and maximum 8 weeks; 3 times a week; Other Names: weight training , walking, cycling etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in six minute walk test	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	8 weeks pre-op and 1 week pre-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative complications	Postoperative complications including surgical site infection, other infectious complications (such as pneumonia, urinary tract infection, line sepsis), bile leak, hemmorrhage, deep vein thrombosis, etc., will be recorded and scored using the Clavien Classification.	30 days
Health-related quality of life (HRQL)	Health-related quality of life (HRQL) as measured by the acute (1 week recall period) SF-36 health survey. The SF-36 is the most widely used HRQL measure and has been validated for surgical population; Canadian norms are also available.	8 and 1 week pre-operatively, 4 and 8 weeks post-operatively
Physical activity level	Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire. The CHAMPS is a self-reported measure of physical activity, comprising 41 activities evaluated according to the total number of hours done during an average week.	8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively
Depression and anxiety	Depression and anxiety will be assessed by The Hospital Anxiety and Depression Scale (HADS), a 14-question measure with seven items each for depression and anxiety. HADS generates separate scores for anxiety and depression as well as a combined score of psychological distress.	8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively
Fatigue	Fatigue will be assessed using a visual analog scale (1-10) and the Brief Fatigue Inventory (BFI). The BFI assesses the level of fatigue and its impact on activities of daily living44	8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively
Nutritional status	Nutritional status will be assessed through subjective and objective evaluations.Body composition will be measured by bioimpedance assay.Assessment of usual food intake will be performed using the 3-day, 24-hour food recall method. The scored Patient Generated Subjective Global Assessment (sPG-SGA) is a validated questionnaire used to assess the nutritional and functional status of cancer patients.	8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Prosanto Chaudhury, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: February 16, 2012
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Estimate): March 2, 2012
• Last Update Submitted That Met QC Criteria: February 24, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: liver resection; hepatectomy; pre-habilitation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Liver Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Biliary Tract Diseases; Neoplasms; Colorectal Neoplasms; Liver Neoplasms; Biliary Tract Neoplasms
• Other Study ID Numbers: BMA-10-375