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
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.
Study Type
Interventional
Primary Outcome
Change in functional walking capacity as measured by the six-minute walk test (6MWT)
Secondary Outcome
Timed up and go test
Condition
Pancreatic Cancer
Intervention
Exercise
Study Arms / Comparison Groups
Prehabilitation
Description: Exercise, nutrition and relaxation techniques all beginning four weeks prior to surgery date.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
60
Start Date
February 22, 2017
Completion Date
December 31, 2019
Primary Completion Date
December 31, 2019
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
Gender
All
Ages
18 Years - 95 Years
Accepts Healthy Volunteers
No
Contacts
Antonio Vigano, MD, MSc, 514-934-1934, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT03475966
Organization ID
prehab_pilot
Responsible Party
Principal Investigator
Study Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Dr. Franco Carli
Study Sponsor
Antonio Vigano, MD, MSc, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date
May 2019