Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carbohydrate-rich, dietary supplement: PreOp® 800ml day before surgery and PreOp® 400ml 2-4hours preoperative.

Standard of care: Fasting from 24hours (midnight), night before surgery.

PreOp®

Per Reidar Woldbæk, MD, PhD

Astrid B. Krohn-Hansen, bachelor

Per Reidar Woldbaek, MD, PhD

Astrid Krohn-Hansen, RN

Administration of preoperative oral carbohydrates are suggested to reduce insulin resistance due to surgical stress.

The aim of this study is to investigate whether preoperative oral carbohydrate loading can contribute to lower incidence of postoperative discomfort and to reduce complications in elective lung cancer patients undergoing video assisted thorascopic surgery (VATS).

Fasting from 6-12hours before elective surgery is still standard of care in many departements, including our departement in Oslo University Hospital.

Surgery is a trauma that triggers a catabolic stress response with high emissions of hormones and immune activation. These activations can affect brain, heart, muscles and liver. The metabolic changes may in addition influence development of pain, tissue damage, ileus, tachycardia and other hemodynamic disturbances. Preoperative fasting has shown an increase of surgical stress and to impact catabolic processes which secondarily may lead to insulin resistance and hyperglycemia in non-diabetic patients. Insulin resistance and hyperglycaemia are known to increase the incidence of postoperative infections. Previous studies have also shown that prolonged fasting increases the incidence of gastrointestinal problems. A 12 hour fast before surgery has shown delayed recovery.

Studies have shown that patients undergoing lung cancer surgery suffer from multiple symptoms and experience discomfort in the postoperative phase. Symptoms include dyspnea, fatigue, pain, weakness, cough, dry mouth, nervousness, difficulty sleeping, stomach-/intestinal-problems and lack of appetite. Carbohydrate-rich supplements have shown a positive effect on other perioperative symptoms and measures, but is to our knowledge currently not investigated in lung cancer surgery.

Therefore, there is a need to explore the possible advantages of preoperative oral carbohydrate loading in lung cancer surgery.

The primary aim of this study is to investigate whether preoperative carbohydrate loading with PreOp® provides less postoperative discomfort in the early postoperative phase measured by Quality of Recovery-40 (QoR-40), a validated and widely used measure of quality of recovery.

The secondary aim is to investigate if preoperative loading with carbohydrates affect the incidence of postoperative complications such as stomach-/intestinal problems and heart rhythm disorder, in addition to contribute to faster mobilization and to reduce hospital length of stay.

This study may provide important data regarding the lung cancer patients perioperative symptoms, complications and well-being when using a carbohydrate-rich supplement as intervention to standard of care.

In this study, the intervention group will be given 800ml of a oral carbohydrate supplement, PreOp®, the night before surgery and 400ml of the same supplement, PreOp®, 2-4 hours prior to surgery. The control group will be fasted from 24h, the night before surgery, in accordance to the departements standard of care.

Both groups, the interventional and the control group, will follow the department's perioperative course with regard to anesthetic and surgical procedures.

Preoperative Loading With Carbohydrates in Lung Cancer Surgery

Postoperative discomfort measured by the questionnaire "Quality of recovery 40" (QoR-40) measured on the first postoperative day.

Number of patients experiencing nausea, vomiting, diarrhea and/or obstipation.

Number of patients with arrhythmia lasting more than 5 min or treated with antiarrhythmic agents.

Time to mobilization out of bed (to chair or walking) as registered by the attending nurse.

Length of hospital stay to discharge for index admission.

Oslo University Hospital

MD, PhD

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Overweight

Obesity

Overnutrition

Nutrition Disorders

Body Weight

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

consume both high and low glycemic load diets for 28 days each

Low Glycemic Load Diet

High Glycemic Load Diet

Marian Neuhouser, RD, PhD

This study is designed to investigate associations of low- and high-glycemic load diets with biomarkers of hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk.

This is a randomized, crossover feeding study conducted in normal weight and overweight individuals. Participants will be given all their food to eat and drink (except water) for two 28-day feeding periods (a total of 56 days). The diets will be carefully controlled and energy intake will be regulated to maintain weight stability for each participant. The two feeding periods will be separated by a 28 day "washout" period when participants will eat their own food. Dinner will be eaten at the Hutchinson Center Monday through Friday. Each evening, breakfast, lunch and snacks will be brought home for the next day. On Friday evenings all the food will be taken home for the weekend.

Samples of blood will be collected after an overnight fast at the beginning and the end of each feeding period. All urine will be collected for 24 hours at the end of each feeding period. A number of questionnaires will also be completed during each diet period. A small stool sample will be collected in your own home, before the first feeding period, and once during each feeding period. The stool sample collection is optional. One can decide not to provide a stool sample and still participate in the study.

Carbohydrates and Related Biomarkers

A Feeding Study to Examine the Effect of Glycemic Load and Obesity on Cancer Biomarkers

National Cancer Institute (NCI)

Fred Hutchinson Cancer Center

Marian Neuhouser

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Malnutrition

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Micronutrients

Vitamins

Trace Elements

Enteral nutrition composed of carbohydrates and vitamins

carbohydrates

vitamins

Evaluation of the impact of preoperative nutritional support on clinical outcomes in patients at nutritional risk. The primary endpoint was the complication rate and the second endpoint was the length of stay.

Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002

Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002- A Prospective, Randomized Clinical Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preoperative Loading With Carbohydrates in Lung Cancer Surgery	NCT03070626	Lung Neoplasm	PreOp®	18 Years -	Oslo University Hospital
Preoperative Loading With Carbohydrates in Lung Cancer Surgery	NCT03070626	Lung Neoplasm	PreOp®	18 Years -	Oslo University Hospital
Carbohydrates and Related Biomarkers	NCT00622661	Healthy Overweight	Low Glycemic Lo... High Glycemic L...	18 Years - 45 Years	Fred Hutchinson Cancer Center
Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002	NCT01830907	Malnutrition Gastric Cancer	carbohydrates vitamins	18 Years - 85 Years	The First Hospital of Jilin University
Carbohydrates and Related Biomarkers	NCT00622661	Healthy Overweight	Low Glycemic Lo... High Glycemic L...	18 Years - 45 Years	Fred Hutchinson Cancer Center

Spots Global Cancer Trial Database for carbohydrates