Spots Global Cancer Trial Database for Early Enteral Nutritional Supplementation on Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical

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Trial Identification

Brief Title: Early Enteral Nutritional Supplementation on Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical

Official Title: A Prospective, Randomized, Clinical Study to Evaluate the Effects of Early Enteral Nutritional Supplementation on Clinical Outcomes in Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical Resection

Study ID: NCT03545490

Conditions

Malnutrition

Interventions

Early nutritional intervention

Study Description

Brief Summary: The target population in the present study is Chinese patients with oral and oropharyngeal cancer who plan to receive radio(chemo)therapy after surgical resection in the outpatient department. Investigators hypothesize that early enteral nutrition intervention, which is initiated 2 weeks before the start of postoperative radio(chemo)therapy treatment and added on demand during radiotherapy, will improve patients' nutritional status, tolerability to the radio(chemo)therapy, quality of life, and other clinical outcomes compared to commencement of oral nutritional supplements during the course of irradiation treatment. There are two cohorts in this trial, cohort 1 included patients with oral nutritional supplements and cohort 2 included patients with tube feeding (nasogastric tube or percutaneous endoscopic gastrostomy).

Detailed Description: This clinical trial will be conducted in a single-center, prospective, and randomized manner. In this protocol, the standard radio(chemo)therapy duration is 6-7 weeks. Early enteral nutrition intervention (EEN) refers to starting enteral nutrition intervention 2 weeks before post-operative radio(chemo)therapy begins and stopping this intervention when post-operative radio(chemo)therapy completes. Standard enteral nutrition intervention (SEN) refers to starting of enteral nutrition intervention on demand during (chemo)radiotherapy. Nutritional supplementation was given either through the oral route (Cohort 1) or tube feeding (nasogastric tube or percutaneous endoscopic gastrostomy, cohort 2). Dietitians will design meal plans for both groups of subjects so that their normal diets will provide 25-30 kcal/d/kg body weight in addition to nutritional supplements.