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Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID05892354

Study of Immunonutrition to Reduce Oral Mucositis in Adults with Advanced Nasopharyngeal Cancer Receiving Chemoradiotherapy

Led by First Affiliated Hospital of Guangxi Medical University · Updated on 2024-08-07

190

Participants Needed

20

Research Sites

100 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to assess whether immunonutrition can reduce oral mucositis compared with standard nutrition in patients with locally advanced nasopharyngeal carcinoma receiving chemoradiotherapy. Oral mucositis is a common and severe side effect in these patients, causing pain, difficulty swallowing, and malnutrition, which can disrupt treatment and worsen quality of life and prognosis. Nutritional interventions like immunonutrition may help improve immune response, reduce inflammation, and enhance treatment tolerance and outcomes. Participants receive induction chemotherapy with gemcitabine and cisplatin followed by concurrent chemoradiotherapy with intensity-modulated radiotherapy and cisplatin. They are randomly assigned to one of two groups one group receives enteral immunonutrition Oral Impact twice daily starting 5 days before radiotherapy until treatment ends, while the other group receives a standard enteral nutrition formula ENSURE three times daily over the same period. During the study, participants are monitored for the incidence, timing, and duration of severe oral mucositis over 7 weeks. Researchers also assess immune status, inflammatory markers, nutritional and physical function, quality of life, and survival rates up to 2 years after randomization. Safety and adverse events are recorded throughout the study. Participants are expected to follow scheduled visits, laboratory tests, and questionnaires.

CONDITIONS

Brief Title

Effect of Immunonutrients on Oral Mucositis in Nasopharyngeal Carcinoma Patients After Chemoradiotherapy

Research Team

Z

Zhen Meng, M.D

Y

Yating Qin, M.D

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