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Arginine

Perioperative Oral Nutritional Supplementation

Placebo of Perioperative Oral Nutritional Supplementation

Oral nutritional supplement containing L-arginin, ω3 polyunsaturated fatty acids, and nucleotides. Given three times a day for the 7 last preoperative and the first 3 postoperative days.

Oral Impact®

Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days.

Placebo

Yannick Mallédant, MD

Eric Bellissant, MD, PhD

Philippe Seguin, MD

Karim Boudjema, MD, PhD

Cirrhotic patients undergoing hepatic resection have a mortality rate near 10%, and 30 to 70% of them develop severe complications. These failures are mainly due to hepatic insufficiency. Studies have already shown benefits of oral nutritional supplements in ORL, digestive, and cardiac surgery. We aimed to ascertain whether this nutritional, immune-enhancing supplementation, administered 7 days before and 3 days after surgery, could improve liver function and postoperative host defences in patients with liver cancer resection.

In patients undergoing hepatic resection for liver cancer (with cirrhosis or fibrosis liver), mortality rate can reach 10% and morbidity (ascites, icteria, infections) 70%. These complications are mainly due to hepatic insufficiency: surgery leaves a reduced parenchyma, with oxidative stress lesions due to reperfusion injury. A good preoperative nutritional state has been shown to reduce complications and mortality. This can be amplified by preoperative nutrition with supplements containing L-arginin, ω3 polyunsaturated fatty acids, and nucleotides which boost immune responses, resistance to infections and liver function recovery. In this context, the study randomly assigns 50 patients who were scheduled to undergo hepatic resection, to receive either an oral immune-enhancing nutritional supplement or a placebo, for the 7 last preoperative and the first 3 postoperative days. The aim of the study is to evaluate the effects of this supplementation on liver function, immunity, and incidence of infections after surgery.

Effect of a Perioperative Oral Nutritional Supplementation on Patients Undergoing Hepatic Surgery for Liver Cancer

Prospective, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Effect of Oral Immune-Enhancing Nutritional Supplement on Hepatic Function After Liver Resection for Primary or Secondary Cancer on Cirrhosis or Liver Fibrosis

Ministry of Health, France

Novartis

Rennes University Hospital

Direction of Clinical Research and Strategy

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Head and Neck Neoplasms

Stomatitis

Nasopharyngeal Carcinoma

Mucositis

Gastroenteritis

Mouth Diseases

Stomatognathic Diseases

Oral immunomodulating formula (Oral Impact®, Nestle) One sachet of Oral Impact® consisted of 74 g of powder providing 303 kilocalories.

Three ready-to-drink bottles contained 303 kilocalories/bottle per day, starting 5 days before each chemotherapy session.

An isocaloric isonitrogenous standard enteral nutrition formula. Three ready-to-drink bottles contained 303 kilocalories/bottle per day, starting 5 days before each chemotherapy session.

This study evaluated the benefits of immunonutrition regarding the prevention of severe mucositis. Patients with head and neck cancer (HNC) undergoing definitive concurrent chemoradiation including 3-week cycles of cisplatin were enrolled in this double-blind phase II study. Patients were randomly assigned to receive an immunonutrition containing omega-3-fatty acids, arginine, dietary nucleotides, and soluble fiber or an isocaloric isonitrogenous control. All patients received the assigned product 5 days before each chemotherapy session. The proportion of patients with severe mucositis was compared between the immunonutrition and control groups.

Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation

Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation: A Phase II Randomized, Double-blind Study

Proportion of severe oral mucositis between two groups

Proportion of patients with other treatment-related toxicities between two groups

mean changes of body weight between two groups

mean actual dose of radiation between two groups

mean cumulative dose of cisplatin between two groups

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of a Perioperative Oral Nutritional Supplementation on Patients Undergoing Hepatic Surgery for Liver Cancer	NCT00151671	Liver Cancer Hepatocellular ... Cirrhosis Liver Fibrosis	Oral Impact® Placebo	18 Years -	Rennes University Hospital
Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation	NCT05101889	Oral Mucositis	Oral Impact®	18 Years - 65 Years	Prince of Songkla University
Benefits of Immunonutrition in Patients With Head and Neck Cancer Receiving Chemoradiation	NCT05101889	Oral Mucositis	Oral Impact®	18 Years - 65 Years	Prince of Songkla University

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