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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
Prosanto Chaudhury, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01542281
First received: February 16, 2012
Last updated: February 24, 2012
Last verified: February 2012
  Purpose
  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.

Condition Intervention
Colorectal Neoplasm
Biliary Tract Neoplasm
Liver Neoplasm
Dietary Supplement: Whey protein and dietary supplements
Other: prehab exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Outcomes in Patients With Hepatobiliary Cancers With a Nutritional and Physical Conditioning Pre-habilitation Program

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Change in six minute walk test [ Time Frame: 8 weeks pre-op and 1 week pre-op ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • post-operative complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.

  • Health-related quality of life (HRQL) [ Time Frame: 8 and 1 week pre-operatively, 4 and 8 weeks post-operatively ] [ Designated as safety issue: No ]
    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.

  • Physical activity level [ Time Frame: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively ] [ Designated as safety issue: No ]
    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.

  • Depression and anxiety [ Time Frame: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively ] [ Designated as safety issue: No ]
    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.

  • Fatigue [ Time Frame: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively ] [ Designated as safety issue: No ]
    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

  • Nutritional status [ Time Frame: 8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 64
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: weight training , walking, cycling etc.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542281

Contacts
Contact: Ayat Salman, MSccandidate 5149341934 ext 36237 ayat.salman@muhc.mcgill.ca

Locations
Canada, Quebec
Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A1A1
Contact: Ayat Salman, MSccandidate    5149341934 ext 36237    ayat.salman@muhc.mcgill.ca   
Principal Investigator: Prosanto Chaudhury, MD         
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Prosanto Chaudhury, MD McGill University Health Center
  More Information

No publications provided

Responsible Party: Prosanto Chaudhury, HPB and Transplant Surgeon, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01542281     History of Changes
Other Study ID Numbers: BMA-10-375
Study First Received: February 16, 2012
Last Updated: February 24, 2012
Health Authority: Canada: Health Canada

Keywords provided by McGill University Health Center:
liver resection
hepatectomy
pre-habilitation

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Neoplasms
Colorectal Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases

ClinicalTrials.gov processed this record on August 19, 2014