Improving Outcomes in Cancer Patients With a Nutritional and Physical Conditioning Prehabilitation Program
Primary Purpose
Pancreatic Cancer, Liver Cancer, Bile Duct Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Nutrition
Relaxation techniques
Sponsored by
About this trial
This is an interventional supportive care trial for Pancreatic Cancer focused on measuring Nutrition, Exercise, Relaxation techniques, Prehabilitation
Eligibility Criteria
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
Sites / Locations
- McGill University Health CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prehabilitation
Rehabilitation
Arm Description
Exercise, nutrition and relaxation techniques all beginning four weeks prior to surgery date.
Exercise, nutrition and relaxation techniques all beginning immediately after surgery.
Outcomes
Primary Outcome Measures
Change in 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. 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.
Secondary Outcome Measures
Timed up and go test
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.
30-second sit to stand test
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.
30-second arm curl test
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.
Change in handgrip strength
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.
Change in body composition
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.
Assessment of food intake and change over study period
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.
Perioperative data
This data will include operative characteristics, transfusion rates, length of surgery, intraoperative complications and length of stay.
Postoperative complications
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.
Health-related quality of life (HRQL) - assessment of change over time
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.
The Edmonton Symptom Assessment System (ESAS) - assessment of change over time
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.
Physical activity level - assessment of change over time
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.
Nutritional status - assessment of change over time
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.
Fatigue - assessment of change over time
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.
Weight - assessment of change over time
Body weight will be measured (Kg)
Height
Height will be measured with a stadiometer (m)
Body mass index - assessment of change over time
Calculated wt (kg)/ht^2 (m)
Blood pressure - assessment of change over time
Systolic and diastolic at rest (mmHg)
Heart rate - assessment of change over time
Beats per minute measured using a pulse oximeter
Full Information
NCT ID
NCT03475966
First Posted
February 28, 2017
Last Updated
December 6, 2020
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Dr. Franco Carli
1. Study Identification
Unique Protocol Identification Number
NCT03475966
Brief Title
Improving Outcomes in Cancer Patients With a Nutritional and Physical Conditioning Prehabilitation Program
Official Title
Improving Outcomes in Patients With Hepatobiliary and Pancreatic Cancers With a Nutritional and Physical Conditioning Prehabilitation Program
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Dr. Franco Carli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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:
Exercise that may help participants move and breath better,
Nutrition advice and a supplement to make participants strong,
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Liver Cancer, Bile Duct Cancer, Hepatobiliary Cancer, Surgery
Keywords
Nutrition, Exercise, Relaxation techniques, Prehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation
Arm Type
Experimental
Arm Description
Exercise, nutrition and relaxation techniques all beginning four weeks prior to surgery date.
Arm Title
Rehabilitation
Arm Type
Active Comparator
Arm Description
Exercise, nutrition and relaxation techniques all beginning immediately after surgery.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Nutrition
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation techniques
Intervention Description
Patients will see a psychologist who will provide relaxation techniques (eg. imagery, visualization, deep breathing exercises) to help patients manage anxiety prior to surgery.
Primary Outcome Measure Information:
Title
Change in functional walking capacity as measured by the six-minute walk test (6MWT)
Description
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.
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Secondary Outcome Measure Information:
Title
Timed up and go test
Description
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.
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Title
30-second sit to stand test
Description
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.
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Title
30-second arm curl test
Description
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.
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Title
Change in handgrip strength
Description
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.
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Title
Change in body composition
Description
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.
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Title
Assessment of food intake and change over study period
Description
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.
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Title
Perioperative data
Description
This data will include operative characteristics, transfusion rates, length of surgery, intraoperative complications and length of stay.
Time Frame
7 days post-operatively
Title
Postoperative complications
Description
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.
Time Frame
4 weeks post-operatively
Title
Health-related quality of life (HRQL) - assessment of change over time
Description
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.
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Title
The Edmonton Symptom Assessment System (ESAS) - assessment of change over time
Description
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.
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Title
Physical activity level - assessment of change over time
Description
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.
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Title
Nutritional status - assessment of change over time
Description
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.
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Title
Fatigue - assessment of change over time
Description
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.
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Title
Weight - assessment of change over time
Description
Body weight will be measured (Kg)
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Title
Height
Description
Height will be measured with a stadiometer (m)
Time Frame
Baseline
Title
Body mass index - assessment of change over time
Description
Calculated wt (kg)/ht^2 (m)
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Title
Blood pressure - assessment of change over time
Description
Systolic and diastolic at rest (mmHg)
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Title
Heart rate - assessment of change over time
Description
Beats per minute measured using a pulse oximeter
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Other Pre-specified Outcome Measures:
Title
Lower extremity strength - assessment of change over time
Description
Optional measure: assessed using the Biodex System 3 (Biodex Medical Systems, Shirley, NY).
Time Frame
Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Vigano, MD, MSc
Phone
514-934-1934
Ext
78716
Email
antonio.vigano@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Vigano, MD, MSc
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3S5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Vigano, MD, MSc
Phone
514-934-1934
Ext
78716
Email
antonio.vigano@mcgill.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Outcomes in Cancer Patients With a Nutritional and Physical Conditioning Prehabilitation Program
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