Effect of Nutritional Management on RIOM in Patients With Advanced Head and Neck Cancer

Study Overview
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Brief Summary
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The goal of this clinical trial is to learn about the effect of nutritional management on radiation-induced oral mucositis in patients with advanced head and neck cancer during the peri-radiotherapy period . The main questions it aims to answer are: [question 1]Whether whole-course nutritional intervention can improve radiation-induced oral mucositis in patients with HNC. [question 2]Whether whole-course nutritional intervention can improve nutritional status and inflammation. Participants will be treated according to the NCCN guidelines. In addition, clinical pharmacists and registered dietitians provided nutritional intervention strategies based on clinical and nutritional assessments for the patients in the peri-radiotherapy nutrition group. Researchers will compare clinical routine examination and nutritional indicators between the standard treatment group and the peri-radiotherapy nutrition management group to see if nutrition management effects.

Official Title
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A Prospective Single-arm Cohort Study on the Effect of Peri-radiotherapy Nutrition Management on Radiation-induced Oral Mucositis in Patients With Advanced Head and Neck Cancer

Conditions
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Head and Neck Cancer, Nutrition Related Cancer, Radiation-Induced Mucositis

Intervention / Treatment
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* Behavioral: nutrition management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 80 years old Advanced head and neck cancer (III-IV inoperable) is clearly diagnosed Predicted survival time > 3 months Radical radiotherapy combined with chemotherapy or immunotherapy was performed in our hospital The patient has clear consciousness and no communication disorder Informed consent and voluntary participation in this study Exclusion Criteria: Patients with previous surgery or radiotherapy for head and neck cancer Patients with concurrent or previous history of other tumors Distant metastasis Patients with allergy, intolerance or contraindication to enteral nutrition or parenteral nutrition Severe renal insufficiency (eGFR<30ml/min/1.73m2) Combined with poorly controlled metabolic diseases such as diabetes Doctors or researchers deem that they are not suitable to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Group A: standard treatment group, standard anti-tumor treatment, clinicians in accordance with the NCCN anti-tumor treatment guidelines. Group B: peri-radiotherapy nutrition management group, standard anti-tumor therapy combined with peri-radiotherapy nutrition management.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Peri-radiotherapy nutrition management group<br>Nutritional management was performed by clinical pharmacists and registered dietitians to develop nutritional intervention strategies based on patient clinical assessment and nutritional assessment. PG-SGA score was 0-3 points, and diet guidance was given. PG-SGA score > 4 points, artificial nutrition intervention was carried out, and the way and amount of nutritional intervention were clarified to achieve the final daily energy and protein target requirements. Nutritional interventions and assessments were adjusted over time. | Behavioral: nutrition management<br>* Nutritional management was performed by clinical pharmacists and registered dietitians to develop nutritional intervention strategies based on patient clinical assessment and nutritional assessment. PG-SGA score was 0-3 points, and diet guidance was given. PG-SGA score > 4 points, artificial nutrition intervention was carried out, and the way and amount of nutritional intervention were clarified to achieve the final daily energy and protein target requirements. Nutritional interventions and assessments were adjusted over time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of radiation-induced oral mucositis (RTOG criteria) | The Radiation Oncology Group (RTOG) grade of acute radiation injury was used for evaluation, which was divided into 0 to Ⅳ grades. The mild grade included 0, Ⅰ, and Ⅱgrades (grade 0 was no mucosal response; GradeⅠ: erythema, mild pain; GradeⅡ: spotty mucositis with serous exudation), severe grade Ⅲ- IV (Ⅲ: patchy fibrous mucositis with severe pain; Grade IV: necrosis, ulcer, hemorrhage). | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck Cancer, Malnutrition, Radiation-induced Oral Mucositis, nutrition management