Clinical study on prevention and treatment of radiation acute oral mucositis in patients with nasopharyngeal carcinoma by self-prepared Chinese herbal compound preparatio

Phase 1

Recruiting

• Conditions: Radiation acute oral mucositis in a patient with nasopharyngeal carcinoma

• Registration Number: ITMCTR2100004944
• Lead Sponsor: Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with locally advanced nasopharyngeal carcinoma diagnosed by pathology and UICC/AJCC TNM staging of stage III and stage A in the 8th edition;
2. Has indications for radical concurrent radiotherapy and chemotherapy, and is scheduled to receive (IMRT technique for radiotherapy, platinum-containing regimen for chemotherapy), and has received radiotherapy for the first time, and has not received surgical treatment;
3. Kanofsky Performance Status (KPS) score >= 70;
4. Blood routine, normal liver and kidney function, and good blood glucose control in diabetic patients (fasting blood glucose 3.9-7.2mmol/L, blood glucose 2 hours after meal <= 10.0mmol/L, HbA1c < 7%);
5. Expected survival of at least 6 months;
6. Age between 18 and 70 years old, male or female;
7. Signing the informed consent.

Exclusion Criteria

1. Pregnant women, lactating women, and women of childbearing age who were unable to obtain effective contraception during the trial;
2. Other established oral mucosal diseases and no previous history of salivary gland diseases;
3. Patients with recurrent or residual nasopharyngeal carcinoma;
4. Complicated with serious heart, liver, kidney, hematopoietic system and nervous system diseases, diabetes mellitus with unsatisfactory blood glucose control and mental disorders;
5. Patients with other malignant tumors;
6. People who are known or suspected to be allergic to the drugs in this study;
7. Other circumstances that the researcher considers not suitable for the study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of RTOGIII grade oral mucosa;

Secondary Outcome Measures

Name	Time	Method
Changes in time and severity of oral mucositis;Pain in oral mucositis;Nutritional risk screening NRS2002;