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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peri-radiotherapy nutrition management group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutrition management | Behavioral | 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. |
| 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 â…£ grades. The mild grade included 0, â… , and â…¡grades (grade 0 was no mucosal response; Gradeâ… : erythema, mild pain; Gradeâ…¡: spotty mucositis with serous exudation), severe grade â…¢- IV (â…¢: patchy fibrous mucositis with severe pain; Grade IV: necrosis, ulcer, hemorrhage). | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Shu An, bachelor | Contact | 18801599435 | glyywsa@163.com |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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.
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