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

NCT03475966 | Unknown

• 1 other identifier: prehab_pilot
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Exercise that may help participants move and breath better,
2. 2.Nutrition advice and a supplement to make participants strong,
3. 3.Relaxation and anti-anxiety tips to help cope with the stress of upcoming surgery

Conditions

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

Keywords

Nutrition; Exercise; Relaxation techniques; Prehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in functional walking capacity as measured by the six-minute walk test (6MWT)

  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.

  Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative

Secondary Outcomes (18)

• Timed up and go test

  Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative

• 30-second sit to stand test

  Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative

• 30-second arm curl test

  Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative

• Change in handgrip strength

  Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative

• Change in body composition

  Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative

Other Outcomes (1)

• Lower extremity strength - assessment of change over time

  Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative

Study Arms (2)

Prehabilitation

EXPERIMENTAL

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

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

Rehabilitation

ACTIVE COMPARATOR

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

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

Interventions

Exercise OTHER

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)

Prehabilitation; Rehabilitation

Nutrition OTHER

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.

Prehabilitation; Rehabilitation

Relaxation techniques BEHAVIORAL

Patients will see a psychologist who will provide relaxation techniques (eg. imagery, visualization, deep breathing exercises) to help patients manage anxiety prior to surgery.

Prehabilitation; Rehabilitation

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Dr. Franco Carli: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3S5, Canada

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Liver Neoplasms; Bile Duct Neoplasms; Motor Activity

Interventions

Exercise; Nutritional Status; Relaxation Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Antonio Vigano, MD, MSc

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Vigano, MD, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Supportive and Palliative Care Division; Director, Cancer Rehabilitation (CARE) Program; Director, McGill Nutrition and Performance Laboratory

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 23, 2018
• Study Start: February 22, 2017
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)