An interventional study of Exercise and Nutrition in Pancreatic Cancer, Liver Cancer and Bile Duct Cancer, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2020-12-08.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Supportive care
Among 184 studies in Pancreatic Neoplasms with a site in Canada — 37 open to participants now, 60 under way, 9 of them phase 3. Pancreatic Neoplasms · Canada.
Among the 184 studies in Pancreatic Neoplasms with a site in Canada, this one is the 111th largest by planned enrollment of the 161 interventional ones that give a count, is one of 12 that started in 2017, is one of 21 with no phase, and was the 96th registered.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
Browse Pancreatic Neoplasms studies →37 of the 184 studies in Pancreatic Neoplasms with a site in Canada are open now. Recruiting first, the newest first:
Bristol-Myers Squibb · Sites in Canada, United States, Belgium and 10 more countries
Verastem, Inc. · Sites in Canada, United States, Australia and 1 more country
University Health Network, Toronto · Sites in Canada
Unity Health Toronto · Sites in Canada
Incyte Corporation · Sites in Canada, United States, Australia and 19 more countries
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 746 Pancreatic Neoplasms studies recruiting now, 479 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.
This study: 18 Years to 95 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
184 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 55 · Phase 2 71 · Phase 3 39 · Phase 4 1
First in 1998; this study’s year is marked. 12 started in 2017.
This study's planned enrollment of 60 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Median enrollment 119 across the 161 interventional studies, 450 across the 20 observational. Of the 119 that completed or were terminated, 44 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
107 of 184 have an industry lead sponsor. The 10 most frequent:
McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.
McGill University Health Centre/Research Institute of the McGill University Health Centre has 1 study filed under Pancreatic Neoplasms — fewer than ten, so there is no comparison to draw.
20 of the studies in Pancreatic Neoplasms with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05687123National Cancer Institute (NCI)Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors | 2026-12-14 |
| NCT02912949Partner Therapeutics, Inc.A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy) | 2026-12-31 |
| NCT04276857University of SaskatchewanSystemic Therapy With a Loco-regional Treatment in Patients With Locally Advanced Pancreatic Cancer | 2026-12-31 |
| NCT05941507LigaChem Biosciences, Inc.A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors | 2027-01 |
| NCT03816358National Cancer Institute (NCI)Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer | 2027-01-31 |
Among the 184 studies in Pancreatic Neoplasms with a site in Canada, from their registry updates:
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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:
The investigators will see if following this program will have an effect on participants' ability to walk before and after surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Exercise, nutrition and relaxation techniques all beginning four weeks prior to surgery date.
Other: Exercise · Other: Nutrition · Behavioral: Relaxation techniques
Exercise, nutrition and relaxation techniques all beginning immediately after surgery.
Other: Exercise · Other: Nutrition · Behavioral: Relaxation techniques
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)
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.
Patients will see a psychologist who will provide relaxation techniques (eg. imagery, visualization, deep breathing exercises) to help patients manage anxiety prior to surgery.
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.
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Weight - assessment of change over time
Body weight will be measured (Kg)
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Height
Height will be measured with a stadiometer (m)
Time frame: Baseline
Body mass index - assessment of change over time
Calculated wt (kg)/ht\^2 (m)
Time frame: 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)
Time frame: 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
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Lower extremity strength - assessment of change over time
Optional measure: assessed using the Biodex System 3 (Biodex Medical Systems, Shirley, NY).
Time frame: Baseline, pre-operative assessment, 4 weeks post-operative, 8 weeks post-operative
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2017 (actual). Primary completion is estimated for Dec 2021, 58 months after the start.
Of 403 non-industry interventional studies with no phase under Pancreatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 75. This study's planned 58 months is above that.
Counting every sponsor, half of 430 studies reached it within 44 months; a quarter within 26 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre →