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

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

NCT ID: NCT05721885

Condition: Head and Neck Cancer
Nutrition Related Cancer
Radiation-Induced Mucositis

Conditions: Official terms:
Head and Neck Neoplasms
Mucositis

Conditions: Keywords:
Head and Neck Cancer
Malnutrition
Radiation-induced Oral Mucositis
nutrition management

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention 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.

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: nutrition management
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.
Arm group label: Peri-radiotherapy nutrition management group

Summary: 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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Start date: March 1, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: Jing Yan
Agency class: Other

Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05721885