Clinical trial NCT03475966: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Liver Cancer
Bile Duct Cancer
Hepatobiliary Cancer
Surgery
Keywords: Nutrition
Exercise
Relaxation techniques
Prehabilitation
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Dr. Franco Carli
First posted: 2018-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in functional walking capacity as measured by the six-minute walk test (6MWT)
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Secondary outcomes:
measure: Timed up and go test
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
measure: 30-second sit to stand test
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
measure: 30-second arm curl test
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
measure: Change in handgrip strength
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
measure: Change in body composition
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
measure: Assessment of food intake and change over study period
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
measure: Perioperative data
timeFrame: 7 days post-operatively
measure: Postoperative complications
timeFrame: 4 weeks post-operatively
measure: Health-related quality of life (HRQL) - assessment of change over time
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
measure: The Edmonton Symptom Assessment System (ESAS) - assessment of change over time
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
measure: Physical activity level - assessment of change over time
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
measure: Nutritional status - assessment of change over time
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
measure: Fatigue - assessment of change over time
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
measure: Weight - assessment of change over time
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
measure: Height
timeFrame: Baseline
measure: Body mass index - assessment of change over time
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
measure: Blood pressure - assessment of change over time
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
measure: Heart rate - assessment of change over time
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Other outcomes:
measure: Lower extremity strength - assessment of change over time
timeFrame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Antonio Vigano, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: