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

Jing Yan

Status: Not yet enrolling

Conditions: Radiation-Induced Mucositis; Head and Neck Cancer; Nutrition Related Cancer

Treatments: Behavioral: nutrition management

Study type: Interventional

Funder types: Other

Identifiers

NCT05721885

2022-496-02

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Peri-radiotherapy nutrition management group

Other 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.

Treatment:

Behavioral: nutrition management