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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05721885
• Other study ID #: 2022-496-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Wang Shu An, bachelor
• Phone: 18801599435
• Email: glyywsa[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Mucositis
• Nutrition Related Cancer
• Radiation-Induced Mucositis

Intervention

Behavioral:
• nutrition management
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jing Yan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ? grades. The mild grade included 0, ?, and ?grades (grade 0 was no mucosal response; Grade?: erythema, mild pain; Grade?: spotty mucositis with serous exudation), severe grade ?- IV (?: patchy fibrous mucositis with severe pain; Grade IV: necrosis, ulcer, hemorrhage).	six months