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

McGill University

Status: Unknown

Conditions: Bile Duct Cancer; Surgery; Hepatobiliary Cancer; Liver Cancer; Pancreatic Cancer

Treatments: Other: Exercise; Behavioral: Relaxation techniques; Other: Nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT03475966

prehab_pilot

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Prehabilitation

Experimental group

Description:

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

Treatment:

Other: Exercise

Behavioral: Relaxation techniques

Other: Nutrition

Rehabilitation

Active Comparator group

Description:

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

Treatment:

Other: Exercise

Behavioral: Relaxation techniques

Other: Nutrition