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

Not Applicable
Conditions
Surgery
Pancreatic Cancer
Liver Cancer
Bile Duct Cancer
Hepatobiliary Cancer
Interventions
Other: Exercise
Other: Nutrition
Behavioral: Relaxation techniques
Registration Number
NCT03475966
Lead Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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:

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
60
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PrehabilitationNutritionExercise, nutrition and relaxation techniques all beginning four weeks prior to surgery date.
PrehabilitationRelaxation techniquesExercise, nutrition and relaxation techniques all beginning four weeks prior to surgery date.
RehabilitationExerciseExercise, nutrition and relaxation techniques all beginning immediately after surgery.
PrehabilitationExerciseExercise, nutrition and relaxation techniques all beginning four weeks prior to surgery date.
RehabilitationNutritionExercise, nutrition and relaxation techniques all beginning immediately after surgery.
RehabilitationRelaxation techniquesExercise, nutrition and relaxation techniques all beginning immediately after surgery.
Primary Outcome Measures
NameTimeMethod
Change in functional walking capacity as measured by the six-minute walk test (6MWT)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.

Secondary Outcome Measures
NameTimeMethod
Change in handgrip strengthBaseline, 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.

Postoperative complications4 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.

Fatigue - assessment of change over timeBaseline, 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.

30-second arm curl testBaseline, 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.

Assessment of food intake and change over study periodBaseline, 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.

Nutritional status - assessment of change over timeBaseline, 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.

Body mass index - assessment of change over timeBaseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative

Calculated wt (kg)/ht\^2 (m)

Heart rate - assessment of change over timeBaseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative

Beats per minute measured using a pulse oximeter

Timed up and go testBaseline, 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.

30-second sit to stand testBaseline, 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.

Change in body compositionBaseline, 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.

Perioperative data7 days post-operatively

This data will include operative characteristics, transfusion rates, length of surgery, intraoperative complications and length of stay.

HeightBaseline

Height will be measured with a stadiometer (m)

The Edmonton Symptom Assessment System (ESAS) - assessment of change over timeBaseline, 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.

Blood pressure - assessment of change over timeBaseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative

Systolic and diastolic at rest (mmHg)

Health-related quality of life (HRQL) - assessment of change over timeBaseline, 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.

Physical activity level - assessment of change over timeBaseline, 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.

Weight - assessment of change over timeBaseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative

Body weight will be measured (Kg)

Trial Locations

Locations (1)

McGill University Health Centre

🇨🇦

Montreal, Quebec, Canada

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