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

NCT01542281 | Unknown

• 1 other identifier: BMA-10-375
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To understand which measures of immediate surgical recovery are sensitive to prehabilitation interventions and predict change in later outcome measures.

Conditions

Colorectal Neoplasm; Biliary Tract Neoplasm; Liver Neoplasm

Keywords

liver resection; hepatectomy; pre-habilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• post-operative complications

  30 days

• Health-related quality of life (HRQL)

  8 and 1 week pre-operatively, 4 and 8 weeks post-operatively

• Physical activity level

  8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively

• Depression and anxiety

  8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively

• Fatigue

  8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively

Study Arms (2)

Nutritional supplementation and prehab

EXPERIMENTAL

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

Dietary Supplement: Whey protein and dietary supplements

Prehab exercise

ACTIVE COMPARATOR

Other: prehab exercise

Interventions

Whey protein and dietary supplements DIETARY_SUPPLEMENT

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

Nutritional supplementation and prehab

prehab exercise OTHER

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

Also known as: weight training , walking, cycling etc.

Prehab exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, H3A1A1, Canada

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Biliary Tract Neoplasms; Liver Neoplasms

Interventions

Whey Proteins; Dietary Supplements; Walking

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Biliary Tract Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Prosanto Chaudhury, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayat Salman, MSccandidate

CONTACT

5149341934; ayat.salman@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HPB and Transplant Surgeon

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: March 2, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 2, 2012

Record last verified: 2012-02

Locations

CA (1)