Recruiting

Prehabilitation Program

Sponsor:

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

Code:

NCT03475966

Conditions

Pancreatic Cancer

Liver Cancer

Bile Duct Cancer

Hepatobiliary Cancer

Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise

Nutrition

Relaxation techniques

Study Details

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.

Conditions

Pancreatic Cancer

Liver Cancer

Bile Duct Cancer

Hepatobiliary Cancer

Surgery

Study ID

NCT03475966

Start date

Feb 22, 2017

Status verified date

Dec, 2020

Completion date

Jun 30, 2022

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Prehabilitation

Exercise, nutrition and relaxation techniques all beginning four weeks prior to surgery date.

active comparator: Rehabilitation

Exercise, nutrition and relaxation techniques all beginning immediately after surgery.

Interventions

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)

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.

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Antonio Vigano, MD, MSc

514-934-1934antonio.vigano@mcgill.ca

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3S5

Contacts

Antonio Vigano, MD, MSc

514-934-1934antonio.vigano@mcgill.ca

More Information

Sponsor

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

Last update posted

Dec 8, 2020

Last verified

Dec, 2020

Keywords

  • Nutrition
  • Exercise
  • Relaxation techniques
  • Prehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2020-12-08.