Clinical trial · Interventional
Effect of Nutritional Management on RIOM in Patients With Advanced Head and Neck Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Nutrition Related Cancer | — | UNRESOLVED | — |
| Radiation-Induced Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nutrition management | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Peri-radiotherapy nutrition management group
- description
- 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.
- interventionNames
- Behavioral: nutrition management
Primary outcomes (1)
- measure
- Degree of radiation-induced oral mucositis (RTOG criteria)
- timeFrame
- six months
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available