Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Cholangiocarcinoma

Liver Neoplasms

Bile Duct Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Bile Duct Cancer

Other Dietary Supplements

All Drugs and Chemicals

Whey Protein

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

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

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)

Exercise

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.

Nutrition

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

Relaxation techniques

Antonio Vigano, MD, MSc

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.

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

Improving Outcomes in Patients With Hepatobiliary and Pancreatic Cancers With a Nutritional and Physical Conditioning Prehabilitation Program

Optional measure: assessed using the Biodex System 3 (Biodex Medical Systems, Shirley, NY).

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.

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.

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.

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.

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.

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.

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.

This data will include operative characteristics, transfusion rates, length of surgery, intraoperative complications and length of stay.

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.

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.

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.

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.

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.

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.

Height will be measured with a stadiometer (m)

Beats per minute measured using a pulse oximeter

Dr. Franco Carli

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

Attending Physician, Supportive and Palliative Care Division; Director, Cancer Rehabilitation (CARE) Program; Director, McGill Nutrition and Performance Laboratory

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Immediately after randomization, until surgery and to be continued for 8 weeks after surgery, patients in this arm will:

1. Receive a personalized physical exercise program
2. Receive nutritional counselling with whey protein isolate powder
3. Receive relaxation techniques

Patients in this arm will receive the same personalized physical exercise program, nutritional intervention and relaxation techniques as patient in the other arm but to be started after surgery.

Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Posder (Immunocal) is provided.

Immunocal (1.5g/kg PO (by mouth) per day in daily doses

Whey Protein Isolate Powder

Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.

Physical Exercise Program

Relaxation techniques consisting of breathing exercises and using a relaxation CD

Relaxation Techniques

Franco Carli, MD

The investigators propose a randomized controlled study in patients undergoing lung resection for cancer to compare the impact of multimodal intervention composed of exercise, nutritional supplement and psychological well-being on functional exercise capacity. One group (rehabilitation group) will receive the multimodal intervention after surgery for 8 weeks; the other will start 4 weeks before surgery and continue for 8 weeks postop (prehabilitation group). In this case, both groups will be exposed to the program, which will be available to both groups postoperatively. One of the two groups will start this program 4 weeks before surgery and continue for 8 weeks postoperatively, and the other will start once they leave the hospital and continue for 8 weeks postoperatively.

Interventions

The multidisciplinary program is composed of 3 elements: exercise, nutritional supplements and psychological coping strategies

Exercise program

Patients will be seen by a kinesiologist for a period of 1 hour and he/she will assess patients' mobility and capacity to undertake exercise, will prepare a personalized program and will explain and monitor the exercise program. Patients will be instructed on how to conduct aerobic exercise in the lab and at home, by either walking or cycling initially at 50% of the calculated heart rate reserve for 20 min three times per week, and this will be increased in stepwise increments by 10% each week, if tolerable.

Muscular resistance training will be also carried out 3 times a week to avoid muscle soreness. Persons will be instructed to do push-up, sit-ups, and standing strides (lunges) until volitional fatigue increasing this number to reach 12 repetitions. The resistance chosen for strengthening of biceps, deltoids and quadriceps will be based on what the person can lift to reach volitional fatigue with 8 repetitions.

Psychological program

It is expected that patients undergoing surgery for cancer are anxious with some component of depression. Since both anxiety and depression can influence the motivation to carry out social and functional activities, psychological strategies can be put in place to help patients to cope with the stress of surgery and disease. For this reason patients will be seen by a trained psychologist. Patients will receive a total of 1.5 hours of psychological intervention in the first session and more sessions if necessary.

In the first preoperative session, the first hour will address the patient's anxieties, coping strategies, and post-operative expectations, with the goal of optimizing psychological well-being \& ways of coping with surgery. The importance of the patient's active participation in the healing process will also be discussed. The last thirty minutes will be devoted to teaching relaxation techniques and breathing exercises. Patients will be given a relaxation CD to take home for practice.

Nutritional supplementation

The nutritional status of patients affected by lung cancer is directly influenced by the presence of cancer, which impacts on all aspects of intermediary (protein, carbohydrate, lipid, trace element, vitamin) metabolism, and by other factors such as age, adjuvant cancer therapy and stage of the disease. The greater sensitivity of protein catabolism to nutritional support, in particular to amino acids, could have important implications for the nutritional management of these patients during the period of catabolic stress, with particular emphasis on substrate utilization and energy requirement.

The patients' nutritional status and dietary intake will be assessed by the nutritionist. Percentage of lean body mass and fat percentage will be measured. All patients will receive a daily dietary supplement known as whey protein (Immunocal, Immunotec ©). Special precautions will be considered if patients have specific medical conditions (e.g. diabetes).

Multimodal Prehabilitation to Enhance Functional Recovery After Lung Surgery

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 m 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.

The SF-36 incorporates behavioural functioning, subjective well-being and perceptions of health by assessing, on a 0 to 100 scale, eight health concepts: (1) Physical function (PF) -limitations in physical activities due to health problems; (2) Role physical (RP)-limitations in role activities due to physical health problems; (3) Role emotional (RE) -limitations in usual role activities due to emotional problems; (4) Social functioning (SF) -limitations in social activities due to health problems; (5) Bodily pain (BP)-pain; (6) General health (GH) -general health perceptions; (7) Vitality (VT) -energy and fatigue; and (8) Mental health (MH) -general mental health.

The FACT-L (functional assessment of cancer therapy lung) and EQ-5D, both validated measures, will be used to assess quality of life.

Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire.

The Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety and depression.

Nutritional status will be assessed using body, body weight loss over the preceding three months (\>10%), and/or serum albumin \< 35 g -1 will define poor nutritional status. Hand grip strength and body impedance will also be measured.

Immunotec Inc.

Franco Carli

Symptoms and General Pathology

Colorectal Neoplasms

Postoperative Complications

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Immediately after randomization and until surgery, patients in this arm will:

1. - Receive a personalized physical exercise program
2. - Receive nutritional counselling with Whey protein isolate powder
3. - Receive relaxation techniques

Patients in this arm will receive the same personalized physical exercise program, nutritional intervention and relaxation techniques as patients in the other arm but to be started after surgery.

Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Powder (Immunocal) is provided.

Immunocal1.5g/kg PO (by mouth) per day separated in 2 daily doses

Relaxation techniques consisting of breathing exercises and using a relaxation CD.

Franco Carli, MD, MPhil

The purpose of this study is to determine if a program of physical activity, nutritional supplements and relaxation techniques is effective at decreasing post operative complications in frail colorectal cancer patients undergoing resection.

Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer

Factoring the cost of the program versus possible savings related to other primary and secondary outcomes

Using the Hospital Anxiety Depression Scale (HADS)

Using the Short Form Health Survey (SF-36)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving Outcomes in Cancer Patients With a Nutritional and Physical Conditioning Prehabilitation Program	NCT03475966	Pancreatic Canc... Liver Cancer Bile Duct Cance... Hepatobiliary C... Surgery	Exercise Nutrition Relaxation tech...	18 Years - 95 Years	McGill University Health Centre/Research Institute of the McGill University Health Centre
Multimodal Prehabilitation to Enhance Functional Recovery After Lung Surgery	NCT02938104	Lung Cancer	Whey Protein Is... Physical Exerci... Relaxation Tech...	18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre
Multimodal Prehabilitation to Enhance Functional Recovery After Lung Surgery	NCT02938104	Lung Cancer	Whey Protein Is... Physical Exerci... Relaxation Tech...	18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre
Multimodal Prehabilitation to Enhance Functional Recovery After Lung Surgery	NCT02938104	Lung Cancer	Whey Protein Is... Physical Exerci... Relaxation Tech...	18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre
Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer	NCT02502760	Colorectal Neop...	Physical Exerci... Whey Protein Is... Relaxation Tech...	-	McGill University Health Centre/Research Institute of the McGill University Health Centre

Spots Global Cancer Trial Database for relaxation techniques