Sapylin Versus Dexamethasone Inhalation for CCRT-Induced Oral Mucositis in Nasopharyngeal Carcinoma
Recruiting
Phase 3
Interventional Study
Nasopharyngeal Carcinoma (NPC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 180 (estimated)
- Sponsor
- Affiliated Hospital of Guangdong Medical University · Other
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About This Trial
Radiation therapy is the main treatment for nasopharyngeal carcinoma (NPC), and standard care for advanced NPC often includes combination chemotherapy and radiation (CCRT). However, many patients experience serious side effects, such as painful mouth sores (Radiation-Induced Oral Mucositis, RTOM). These side effects can be so severe that they lower a patient's ability to adhere to treatment, poten…
Trial Locations
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Eligibility Criteria
1. Inclusion Criteria:
* Stage III-IVa NPC (AJCC 8th edition) diagnosed via pathology in a tertiary hospital;
* No previous radiotherapy, chemotherapy, surgery, immunization, or targeted therapy;
* Karnofsky Performance Status score ≥80;
* Intact and normal oral mucosa before treatment;…
Contacts