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Noninferiority of sarperin versus dexamethasone aerosol inhalation in the prevention and treatment of radiation-induced oral mucositis in nasopharyngeal carcinoma: a parallel, randomized controlled study

Noninferiority of sarperin versus dexamethasone aerosol inhalation in the prevention and treatment of radiation-induced oral mucositis in nasopharyngeal carcinoma: a parallel, randomized controlled study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064576
Enrollment
Unknown
Registered
2022-10-12
Start date
2022-10-15
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Radiation-induced oral mucositis

Interventions

Group 1 :Concurrent chemoradiotherapy (CCRT) combined with atomized inhalation of salpeilin
Group 2:CCRT combined with dexamethasone aerosol inhalation

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with locally advanced nasopharyngeal carcinoma (stage II-IV, AJCC 8th edition) pathologically diagnosed by a tertiary hospital; 2. Have not received radiotherapy, chemotherapy, surgery, immunization, targeted therapy, etc. in the past; 3. KPS score >= 70 points; 4. The oral mucosa is intact and normal before treatment; 5. Age: 18-75 years old; 6. Voluntary participation and written informed consent; 7. Blood routine: white blood cells >= 4.0 x 10^9/L; hemoglobin >= 100 g/L; neutrophil count >= 1.5 x 10^9/L; platelet count >= 100 x 10^9/L; 8. Biochemical examination: total bilirubin = 60 ml/min; 9. Cardiopulmonary function is basically normal.

Exclusion criteria

Exclusion criteria: 1. Patients with severe heart, liver, kidney damage or bone marrow dysfunction; 2. Suffering from other malignant tumors in the past or now, or distant metastasis during treatment; 3. Surgery, radiotherapy and chemotherapy, targeted and immunotherapy have been performed; 4. I or my immediate family members have a history of allergic diseases such as bronchial asthma, rash, and urticaria; 5. According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study, such as heart disease, kidney disease, and patients with acute infectious diseases; 6. Female patients who are breast-feeding, pregnant or planning to become pregnant during the study period; 7. Those who are known to be allergic to the therapeutic drugs and penicillin used in the experiment; 8. Those with mental or nervous system disorders or poor compliance.

Design outcomes

Primary

MeasureTime frame
Incidence of radiation-induced oral mucositis;Oral cavity mucous membrane;

Secondary

MeasureTime frame
RTOM occurrence time and duration;

Countries

China

Contacts

Public ContactLuo Haiqing

Affiliated Hospital of Guangdong Medical University

hqluo@126.com+86 13729196345

Outcome results

None listed

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