Improving Outcomes in Cancer Patients With a Nutritional and Physical Conditioning Prehabilitation Program

December 6, 2020 updated by: Antonio Vigano, McGill University Health Centre/Research Institute of the McGill University Health Centre

Improving Outcomes in Patients With Hepatobiliary and Pancreatic Cancers With a Nutritional and Physical Conditioning Prehabilitation Program

Major surgery is a stressful procedure; good recovery after surgery is important to patients and their doctors. Studies done at the McGill University Health Centre (MUHC) with cancer patients awaiting surgery have shown that exercise combined with simple diet recommendations (which may include a supplement) and relaxation techniques before surgery helped speed up the ability to resume walking after surgery.

These results have made the investigators aware that exercise and good nutrition are as important before surgery as they are after surgery; while it is common practice to start strengthening the body after surgery (rehabilitation), there may be some advantage to begin this process before surgery (prehabilitation).

The purpose of this study is to see if the following program, either before or after surgery, can help patients recover from liver, pancreas or bile duct surgery:

  1. Exercise that may help participants move and breath better,
  2. Nutrition advice and a supplement to make participants strong,
  3. Relaxation and anti-anxiety tips to help cope with the stress of upcoming surgery

The investigators will see if following this program will have an effect on participants' ability to walk before and after surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3S5
        • Recruiting
        • McGill University Health Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • A diagnosis or suspicion of either hepatobiliary or pancreatic cancer (primary or metastatic)
  • Must be scheduled for surgical resection between 4-6 weeks of recruitment

Exclusion criteria:

  • Persons with American Society of Anesthesiologists (ASA) health status class 4-5
  • Comorbid medical, physical and mental conditions (eg: dementia, disabling orthopedic and neuromuscular disease, psychosis)
  • Cardiac abnormalities
  • Severe end-organ disease such as cardiac failure, chronic obstructive pulmonary failure and hepatic failure (alanine aminotransferase and aspartate aminotransferase >50% over the normal range)
  • Sepsis
  • Morbid obesity (BMI >40)
  • Anemia (hematocrit <30 %)
  • Other conditions interfering with the ability to perform exercise at home or to complete the testing procedures
  • Poor English or French comprehension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Prehabilitation
Exercise, nutrition and relaxation techniques all beginning four weeks prior to surgery date.
Other: Exercise
A kinesiologist will provide each patient wih an individualized home-based exercise program including aerobic, resistance and stretching exercises. Patients will also exercise at our clinic once per week under the supervision of the kinesiologist (prehabilitation arm only)
Other: Nutrition
Patients will be asked to fill in a 3-day food diary. A registered dietitian (RD) will review this diary, provide a full nutritional assessment, and ensure patients are following a high-protein diet (1.5 g of protein/kg/day). A whey-protein supplement may be provided to patients, should they require it. The RD will also ensure adequate calorie consumption for weight maintenance and will provided advice to help ease any GI issues the patients may be experiencing.
Behavioral: Relaxation techniques
Patients will see a psychologist who will provide relaxation techniques (eg. imagery, visualization, deep breathing exercises) to help patients manage anxiety prior to surgery.
ACTIVE_COMPARATOR: Rehabilitation
Exercise, nutrition and relaxation techniques all beginning immediately after surgery.
Other: Exercise
A kinesiologist will provide each patient wih an individualized home-based exercise program including aerobic, resistance and stretching exercises. Patients will also exercise at our clinic once per week under the supervision of the kinesiologist (prehabilitation arm only)
Other: Nutrition
Patients will be asked to fill in a 3-day food diary. A registered dietitian (RD) will review this diary, provide a full nutritional assessment, and ensure patients are following a high-protein diet (1.5 g of protein/kg/day). A whey-protein supplement may be provided to patients, should they require it. The RD will also ensure adequate calorie consumption for weight maintenance and will provided advice to help ease any GI issues the patients may be experiencing.
Behavioral: Relaxation techniques
Patients will see a psychologist who will provide relaxation techniques (eg. imagery, visualization, deep breathing exercises) to help patients manage anxiety prior to surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional walking capacity as measured by the six-minute walk test (6MWT)
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
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. Subjects are instructed to walk back and forth, in a 20 meter stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines. They are allowed to rest during the test if needed, but this time is included in the 6 minutes. Reference equations are available for calculating percent of age- and gender-specific norm.
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed up and go test
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Investigators will measure the time required for a participant to stand up from being seated, walk a distance of 3 metres, turn around and walk back to the chair, and sit down. This measure will be administered based on Canadian Society for Exercise Physiology standards.
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
30-second sit to stand test
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Investigators will measure the number of times participants can stand from a seated position in 30-seconds. This measure will be administered based on Canadian Society for Exercise Physiology standards.
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
30-second arm curl test
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Investigators will measure the number of times participants can perform a full arm curl in 30-seconds. Both arms will be assessed, one at a time. This measure will be administered based on Canadian Society for Exercise Physiology standards.
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Change in handgrip strength
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
To be measured using the Jamar hydraulic hand dynamometer. Two measures from each hand will be taken, with patient seated and arm bent at a 90-degree angle. The average of the two measures for each hand will be recorded and compared to normative data.
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Change in body composition
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Body composition will be measured via dual-energy X-ray absorptiometry (DXA; Lunar Prodigy Advance, General Electric Healthcare, Madison, WI). Studies from the McGill Nutrition and Performance Laboratory group have validated the use of DXA in advanced cancer patients.
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Assessment of food intake and change over study period
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Participants will be asked to bring a 3-day food diary to their baseline visit to obtain detailed information about the quantity and type of food and beverages consumed during a non-consecutive 3-day period. Overall energy intake, as well as macronutrient distribution (e.g., amount of carbohydrates, fats, proteins, and fibre at each meal) will be calculated using the Food Processor SQL Nutrition Analysis software.
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Perioperative data
Time Frame: 7 days post-operatively
This data will include operative characteristics, transfusion rates, length of surgery, intraoperative complications and length of stay.
7 days post-operatively
Postoperative complications
Time Frame: 4 weeks post-operatively
Including surgical site infection, other infectious complications (such as pneumonia, urinary tract infection, line sepsis), bile leak, hemorrhage, deep vein thrombosis, etc., will be recorded and scored using the Clavien Classification.
4 weeks post-operatively
Health-related quality of life (HRQL) - assessment of change over time
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
As measured by the acute (1 week recall period) Functional Assessment of Cancer Therapy (FACT) survey. This questionnaire also has versions that identify symptoms more specific to hepatobiliary and colorectal cancer patients; this is of relevance to this study given liver metastasis occurs in these patients. The questionnaire is separated into five subscales: 1) physical well-being, 2) social/family well-being, 3) emotional well-being, 4) functional well-being, 5) additional concerns (specific to cancer type). Each question is scored 0-4 on a likert scale, with 0 indicating, "not at all," and 4 indicating, "very much." These scores are then reversed where applicable and added. A higher score indicates better QoL.
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
The Edmonton Symptom Assessment System (ESAS) - assessment of change over time
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Currently used at the MUHC Cedars Cancer Centre to assist in the assessment of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. Each symptom is rated from 0 to 10 on a numerical scale based on severity, with 0 indicating that the symptom is absent and 10 that it is the worst possible severity.
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Physical activity level - assessment of change over time
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
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. Each physical activity is assigned a metabolic equivalent (MET) value yielding average weekly caloric expenditure for the listed physical activities. There is evidence for the validity of CHAMPS as a measure of postoperative recovery. Data will be categorized as either mild, moderate or intense activity and changes in the number of hours spent performing activities within each category will be assessed.
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Nutritional status - assessment of change over time
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
To be assessed using the Abridged Patient-Generated Subjective Global Assessment (aPG-SGA); a validated questionnaire used to assess the nutritional and functional status of cancer patients. The scoring system allows patients at risk for malnutrition to be identified and triaged for nutritional intervention. The aPG-SGA may also be useful in monitoring short-term changes in nutritional status. A score ≥9 indicates a critical need for nutritional intervention.
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Fatigue - assessment of change over time
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
To 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 living. The test has 9 questions: three questions are designed to assess the patient's fatigue during the immediate waking hours and 6 questions address how fatigue has interfered in the patient's life over the previous 24 hours. Each question uses a scale rating from "0" (no fatigue) to "10" (unimaginable fatigue) for a total of 90 points.
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Weight - assessment of change over time
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Body weight will be measured (Kg)
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Height
Time Frame: Baseline
Height will be measured with a stadiometer (m)
Baseline
Body mass index - assessment of change over time
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Calculated wt (kg)/ht^2 (m)
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Blood pressure - assessment of change over time
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Systolic and diastolic at rest (mmHg)
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Heart rate - assessment of change over time
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Beats per minute measured using a pulse oximeter
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower extremity strength - assessment of change over time
Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Optional measure: assessed using the Biodex System 3 (Biodex Medical Systems, Shirley, NY).
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Dr. Franco Carli

Investigators

  • Principal Investigator: Antonio Vigano, MD, MSc, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 22, 2017

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

June 30, 2022

Study Registration Dates

First Submitted

February 28, 2017

First Submitted That Met QC Criteria

March 16, 2018

First Posted (ACTUAL)

March 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 6, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • prehab_pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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