Pancreatic CancerNCT03475966
Improving Outcomes in Cancer Patients With a Nutritional and Physical Conditioning Prehabilitation Program
A study testing Exercise, Nutrition and Relaxation techniques in people with Pancreatic Cancer and Liver Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Pancreatic Cancer, Liver Cancer, Bile Duct Cancer
- What is being tested?
- Exercise, Nutrition and Relaxation techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 22 Feb 2017to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3S5
Antonio Vigano, MD, MSc, 514-934-1934 ext. 78716, antonio.vigano@mcgill.ca
About this study
Official title: Improving Outcomes in Patients With Hepatobiliary and Pancreatic Cancers With a Nutritional and Physical Conditioning Prehabilitation Program
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).
Read more
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:
- Exercise that may help participants move and breath better,
- Nutrition advice and a supplement to make participants strong,
- 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
- Being tested
- Exercise, Nutrition, Relaxation techniques
- Keywords
- Nutrition, Exercise, Relaxation techniques, Prehabilitation
- Medical subject headings
- Pancreatic Neoplasms, Liver Neoplasms, Bile Duct Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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)
NutritionOther
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 techniquesBehavioural
Patients will see a psychologist who will provide relaxation techniques (eg. imagery, visualization, deep breathing exercises) to help patients manage anxiety prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Exercise, nutrition and relaxation techniques all beginning four weeks prior to surgery date. Receives: Other: Exercise; Other: Nutrition; Behavioral: Relaxation techniques |
| Rehabilitation | Active comparator | Exercise, nutrition and relaxation techniques all beginning immediately after surgery. Receives: Other: Exercise; Other: Nutrition; Behavioral: Relaxation techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Secondary outcomes (18)
Timed up and go test
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.
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
30-second sit to stand test
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.
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
30-second arm curl test
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.
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Change in handgrip strength
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.
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Change in body composition
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.
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Assessment of food intake and change over study period
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.
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Perioperative data
This data will include operative characteristics, transfusion rates, length of surgery, intraoperative complications and length of stay.
Measured: 7 days post-operatively
Postoperative complications
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.
Measured: 4 weeks post-operatively
Health-related quality of life (HRQL) - assessment of change over time
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.
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
The Edmonton Symptom Assessment System (ESAS) - assessment of change over time
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.
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Physical activity level - assessment of change over time
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.
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Nutritional status - assessment of change over time
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.
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Fatigue - assessment of change over time
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.
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Weight - assessment of change over time
Body weight will be measured (Kg)
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Height
Height will be measured with a stadiometer (m)
Measured: Baseline
Body mass index - assessment of change over time
Calculated wt (kg)/ht^2 (m)
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Blood pressure - assessment of change over time
Systolic and diastolic at rest (mmHg)
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Heart rate - assessment of change over time
Beats per minute measured using a pulse oximeter
Measured: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start22 Feb 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Franco Carli
- Responsible party
- Principal investigator, Antonio Vigano, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Antonio Vigano, MD, MSc, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475966
- Sponsor's protocol ID
- prehab_pilot
- Status last verified
- Dec 2020
- First submitted
- 28 Feb 2017
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes in Patients With Hepatobiliary and Pancreatic Cancers With a Nutritional and Physical Conditioning Prehabilitation Program
- ClinicalTrials.gov ID
- NCT03475966
- Acronym / sponsor ID
- prehab_pilot
- Conditions
- Pancreatic Cancer, Liver Cancer, Bile Duct Cancer, Hepatobiliary Cancer, Surgery
- Keywords
- Nutrition, Exercise, Relaxation techniques, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Dr. Franco Carli
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Exercise that may help participants move and breath better,
- Nutrition advice and a supplement to make participants strong,
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Other: Exercise, Other: Nutrition, Behavioral: Relaxation techniquesExercise, nutrition and relaxation techniques all beginning four weeks prior to surgery date. |
| Rehabilitation | Active comparator | Other: Exercise, Other: Nutrition, Behavioral: Relaxation techniquesExercise, nutrition and relaxation techniques all beginning immediately after surgery. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseA 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 | Prehabilitation, Rehabilitation |
| NutritionPatients 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. | Other | Prehabilitation, Rehabilitation |
| Relaxation techniquesPatients will see a psychologist who will provide relaxation techniques (eg. imagery, visualization, deep breathing exercises) to help patients manage anxiety prior to surgery. | Behavioural | Prehabilitation, Rehabilitation |
Primary outcome
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.
18 secondary outcomes
Timed up and go test
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
30-second sit to stand test
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
30-second arm curl test
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Change in handgrip strength
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Change in body composition
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Assessment of food intake and change over study period
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Perioperative data
Time frame: 7 days post-operatively
Postoperative complications
Time frame: 4 weeks post-operatively
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
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
Physical activity level - assessment of change over time
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Nutritional status - assessment of change over time
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Fatigue - assessment of change over time
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Weight - assessment of change over time
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Height
Time frame: Baseline
Body mass index - assessment of change over time
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Blood pressure - assessment of change over time
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Heart rate - assessment of change over time
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Vigano, MD, MSc principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Nutrition and Relaxation techniques in people with Pancreatic Cancer and Liver Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Vigano, MD, MSc (514-934-1934 ext. 78716, antonio.vigano@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.