Nutritional and Metabolic Diseases

All Conditions

Neoplasms

Digestive System Diseases

Hyperinsulinism

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Central Nervous System Depressants

Pharmaceutical Solutions

Other Dietary Supplements

Insulin

Insulin, Globin Zinc

Benzocaine

Anabolic Androgenic Steroids

Amino-acid, glucose, and electrolyte solution

Parenteral Nutrition Solutions

Tannic Acid

Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid supplementation) given from start of surgery to 6 hours after, at an amount of 35% of patient's energy expenditure as measured before surgery, .

Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid infusion), given from start of surgery to 6 hours after, at an amount of 20% of patient's energy expenditure as measured before surgery.

Insulin (hyperinsulinemic-normoglycemic clamp, an insulin infusion between 2 and 5 microunits/kg with glucose at a variable rated titrated to maintain normoglycemia, blood glucose 4-6 mmol/L) with no protein supplementation from start of surgery to 6 hours after.

an amino acid supplementation infused intravenously containing essential and non-essential amino acids

Travasol (amino acid injection)

After the insertion of an arterial catheter and obtaining a baseline arterial blood glucose value, 2 units of insluin will be administered iv followed by an infusion of 2 microunits/kg\*min. Ten minuts after starting the insulin, and when the the blood glucose is\<6 mmol/L, dextrose 20% supplemented with phosphate (30mmol/L) will be infused. Blood glucose levels measured every 15 minutes and the dextrose infusion rate adjusted to maintain arterial glycemia between 4 and 6 mmol/L until end of study.

Thomas Schricker, MD

The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.

Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia

The difference in total body protein after randomization to one of the three treatment arms.

Canadian Institutes of Health Research (CIHR)

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

Chief of Anesthesia

Bone Density Conservation Agents

Micronutrients

Vitamins

Vitamin D

Cholecalciferol

Vitamin D3

Calciferol

Multi-Targeted NOSH + Exercise (NOSH Regimen) Arm

Nutrition counseling by a RD and prescribed a eucaloric diet with protein intake of 1.5 g/kg/d and at least 30 g high quality protein per meal. They will be provided 30 grams of high quality protein twice a day, Hydroxymethylbutyrate, and vitamin D3 and multi-vitamin. Participants will attend nutrition and exercise group classes 6-8 weeks. Following following discharge home, participants will be instructed to resume group classes and protein, HMB, vitamin-D and MVS regimen, and exercise classes will resume when cleared by surgical team.

Structured perioperative nutrition and exercise

nutrition counseling by study Registered Dietitian (RD) and prescribed a eucaloric diet with protein intake of 1.0 g/kg/d and a one a day multivitamin/multimineral supplement. They will be counseled on exercising three times per week and given access to exercise videos. Following following discharge home, participants will be instructed to resume protein recommendations and MVS, and exercise recommendations will resume when cleared by surgical team.

Nutrition and Exercise Counseling

Kathryn N Starr, PhD

Kathryn N. Starr, PhD

In this pragmatic clinical trial, the investigators will study older Veterans approaching surgery for gastrointestinal or genitourinary cancer who are at high risk for a marked decline in their physical function. The investigators will test a multi-targeted nutrition regimen high in protein and other key nutrients and including resistance exercise, administered 8 weeks prior to surgery and for 24 weeks after discharge from surgery, with the goal of protecting physical function and improving physiologic, metabolic, and patient-centered outcomes. The findings of this study will promote a better intervention to compensate for the high nutritional demands of cancer and its treatment and lead to stronger, more rapid physical recoveries and better quality of life for older adults with moderate to advanced cancer-a group that has rarely been included in long-term nutrition studies. In addition to providing direct benefits to Veterans, the study may also benefit the VA by decreasing demands on the health care system via hastening the recovery of physical function.

The overall objective of this study is to administer the nutrition optimization of senior health (NOSH) intervention in biphasic intervals and compare it to a typically recommended nutrition regimen (Typical Regimen) for (1) physical function, (2) physiologic and metabolic outcomes; and (3) Veteran-centered outcomes. The central hypothesis is that NOSH will improve physical function. The investigators also predict improvements in physiologic, metabolic and Veteran-centered outcomes. The investigators seek an optimal intervention to alleviate symptom burden and improve function, health, and QoL for older cancer survivors, and the long-term goal is to confirm and implement this intervention. The primary aim is to evaluate the efficacy of a multi-targeted NOSH intervention on physical function. Based on preliminary data, the investigators' working hypothesis is that the NOSH intervention will result in improved physical function before surgery and after surgery relative to the (Typical Regimen).

Preserving Physical Function in Older Adults With Cancer: Impact of an Optimizing Nutrition Intervention Applied Before and After Surgery

SPPB score ranges from 0-12 with 12 being higher function. It assesses balance (side-by-side, semi- and tandem), gait speed (4-m walk), and lower-extremity strength (chair stands).

QLQ-C30 is a patient reported outcome measure designed to assess the functional health (physical, role, emotional, social, cognitive), symptom burden (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea), and health-related quality of life of adults with cancer. Raw scores are transformed to a 0-100 scale, with a higher score representing better functioning/quality of life and greater symptom burden.

PG-SGA is a hands-on assessment of weight, muscle and fat mass, food intake, and nutrition impact symptoms117 using a global rating nutritional diagnosis (A=well nourished, B = moderate/suspected malnutrition, or C=severely malnourished) and a continuous numerical score (1 to 30 - with higher scores representing greater nutritional risk) for intervention triage. The continuous numerical score allows for comparison of changes in nutritional status over short duration of time.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia	NCT02032953	Colorectal Canc...	Travasol (amino... Insulin	18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre
Preserving Physical Function in Older Adults With Cancer: Impact of an Optimizing Nutrition Intervention Applied Before and After Surgery	NCT05912257	Cancer	Structured peri... Nutrition and E...	60 Years -	VA Office of Research and Development

Spots Global Cancer Trial Database for perioperative nutrition