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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004944
Enrollment
Unknown
Registered
2021-06-12
Start date
2021-06-20
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation acute oral mucositis in a patient with nasopharyngeal carcinoma

Interventions

Sponsors

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The incidence of RTOGIII grade oral mucosa;

Secondary

MeasureTime frame
Changes in time and severity of oral mucositis;Pain in oral mucositis;Nutritional risk screening NRS2002;

Countries

China

Contacts

Public ContactZhang Peng

The Tumor Hospital of Sichuan

izhangpeng@163.com+86 13668200277

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026