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

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ClinicalTrials.gov Identifier: NCT03475966
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
Dr. Franco Carli
Information provided by (Responsible Party):
Antonio Vigano, McGill University Health Center

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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Liver Cancer Bile Duct Cancer Hepatobiliary Cancer Surgery Other: Exercise Other: Nutrition Behavioral: Relaxation techniques Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Improving Outcomes in Patients With Hepatobiliary and Pancreatic Cancers With a Nutritional and Physical Conditioning Prehabilitation Program
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Experimental: Prehabilitation
Exercise, nutrition and relaxation techniques all beginning four weeks prior to surgery date.
Other: 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)

Other: 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.

Behavioral: 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.

Active Comparator: Rehabilitation
Exercise, nutrition and relaxation techniques all beginning immediately after surgery.
Other: 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)

Other: 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.

Behavioral: 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 Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Timed up and go test [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    Investigators will measure the time required for a participant to stand up from being seated, walk a distance of 3 metres, turn around and walk back to the chair, and sit down. This measure will be administered based on Canadian Society for Exercise Physiology standards.

  2. 30-second sit to stand test [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    Investigators will measure the number of times participants can stand from a seated position in 30-seconds. This measure will be administered based on Canadian Society for Exercise Physiology standards.

  3. 30-second arm curl test [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    Investigators will measure the number of times participants can perform a full arm curl in 30-seconds. Both arms will be assessed, one at a time. This measure will be administered based on Canadian Society for Exercise Physiology standards.

  4. Change in handgrip strength [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    To be measured using the Jamar hydraulic hand dynamometer. Two measures from each hand will be taken, with patient seated and arm bent at a 90-degree angle. The average of the two measures for each hand will be recorded and compared to normative data.

  5. Change in body composition [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    Body composition will be measured via dual-energy X-ray absorptiometry (DXA; Lunar Prodigy Advance, General Electric Healthcare, Madison, WI). Studies from the McGill Nutrition and Performance Laboratory group have validated the use of DXA in advanced cancer patients.

  6. Assessment of food intake and change over study period [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    Participants will be asked to bring a 3-day food diary to their baseline visit to obtain detailed information about the quantity and type of food and beverages consumed during a non-consecutive 3-day period. Overall energy intake, as well as macronutrient distribution (e.g., amount of carbohydrates, fats, proteins, and fibre at each meal) will be calculated using the Food Processor SQL Nutrition Analysis software.

  7. Perioperative data [ Time Frame: 7 days post-operatively ]
    This data will include operative characteristics, transfusion rates, length of surgery, intraoperative complications and length of stay.

  8. Postoperative complications [ Time Frame: 4 weeks post-operatively ]
    Including surgical site infection, other infectious complications (such as pneumonia, urinary tract infection, line sepsis), bile leak, hemorrhage, deep vein thrombosis, etc., will be recorded and scored using the Clavien Classification.

  9. Health-related quality of life (HRQL) - assessment of change over time [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    As measured by the acute (1 week recall period) Functional Assessment of Cancer Therapy (FACT) survey. This questionnaire also has versions that identify symptoms more specific to hepatobiliary and colorectal cancer patients; this is of relevance to this study given liver metastasis occurs in these patients. The questionnaire is separated into five subscales: 1) physical well-being, 2) social/family well-being, 3) emotional well-being, 4) functional well-being, 5) additional concerns (specific to cancer type). Each question is scored 0-4 on a likert scale, with 0 indicating, "not at all," and 4 indicating, "very much." These scores are then reversed where applicable and added. A higher score indicates better QoL.

  10. The Edmonton Symptom Assessment System (ESAS) - assessment of change over time [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    Currently used at the MUHC Cedars Cancer Centre to assist in the assessment of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. Each symptom is rated from 0 to 10 on a numerical scale based on severity, with 0 indicating that the symptom is absent and 10 that it is the worst possible severity.

  11. Physical activity level - assessment of change over time [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    Will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire. The CHAMPS is a self-reported measure of physical activity, comprising 41 activities evaluated according to the total number of hours done during an average week. Each physical activity is assigned a metabolic equivalent (MET) value yielding average weekly caloric expenditure for the listed physical activities. There is evidence for the validity of CHAMPS as a measure of postoperative recovery. Data will be categorized as either mild, moderate or intense activity and changes in the number of hours spent performing activities within each category will be assessed.

  12. Nutritional status - assessment of change over time [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    To be assessed using the Abridged Patient-Generated Subjective Global Assessment (aPG-SGA); a validated questionnaire used to assess the nutritional and functional status of cancer patients. The scoring system allows patients at risk for malnutrition to be identified and triaged for nutritional intervention. The aPG-SGA may also be useful in monitoring short-term changes in nutritional status. A score ≥9 indicates a critical need for nutritional intervention.

  13. Fatigue - assessment of change over time [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    To be assessed using a visual analog scale (1-10) and the Brief Fatigue Inventory (BFI). The BFI assesses the level of fatigue and its impact on activities of daily living. The test has 9 questions: three questions are designed to assess the patient's fatigue during the immediate waking hours and 6 questions address how fatigue has interfered in the patient's life over the previous 24 hours. Each question uses a scale rating from "0" (no fatigue) to "10" (unimaginable fatigue) for a total of 90 points.

  14. Weight - assessment of change over time [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    Body weight will be measured (Kg)

  15. Height [ Time Frame: Baseline ]
    Height will be measured with a stadiometer (m)

  16. Body mass index - assessment of change over time [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    Calculated wt (kg)/ht^2 (m)

  17. Blood pressure - assessment of change over time [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    Systolic and diastolic at rest (mmHg)

  18. Heart rate - assessment of change over time [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    Beats per minute measured using a pulse oximeter


Other Outcome Measures:
  1. Lower extremity strength - assessment of change over time [ Time Frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative ]
    Optional measure: assessed using the Biodex System 3 (Biodex Medical Systems, Shirley, NY).



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475966


Contacts
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Contact: Antonio Vigano, MD, MSc 514-934-1934 ext 78716 antonio.vigano@mcgill.ca

Locations
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Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H4A 3S5
Contact: Antonio Vigano, MD, MSc    514-934-1934 ext 78716    antonio.vigano@mcgill.ca   
Sponsors and Collaborators
McGill University Health Center
Dr. Franco Carli
Investigators
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Principal Investigator: Antonio Vigano, MD, MSc McGill University Health Center

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Responsible Party: Antonio Vigano, Attending Physician, Supportive and Palliative Care Division; Director, Cancer Rehabilitation (CARE) Program; Director, McGill Nutrition and Performance Laboratory, McGill University Health Center
ClinicalTrials.gov Identifier: NCT03475966     History of Changes
Other Study ID Numbers: prehab_pilot
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antonio Vigano, McGill University Health Center:
Nutrition
Exercise
Relaxation techniques
Prehabilitation

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Liver Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Biliary Tract Neoplasms
Bile Duct Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liver Diseases
Biliary Tract Diseases
Adenocarcinoma
Carcinoma