NCT03545490

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Early nutritional intervention	Early nutritional intervention (Ensure) was given two weeks before radiotherapy. Ensure 3 times per day, Mixing 55.8 g or 6 spoons of Ensure with 190 mL of warm water.

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-10-31
• Completion: 2022-06-30
• First posted: 2018-06-04
• Last updated: 2023-12-18

Locations

1 site across 1 country: China