Clinical trial · Interventional
Appaconitine Patch for Oral Mucositis Pain Caused by Chemoradiotherapy in Patients With Nasopharyngeal Cancer
Efficacy and Safety of Lappaconitine Adhesive Patch for the Treatment of Oral Mucositis Pain Caused by Chemoradiotherapy in Patients With Nasopharyngeal Cancer ： A Randomized, Prospective Single-center Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this clinical study is to evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain and the improvements in QOL of patients with nasopharyngeal carcinoma . To determine if lappaconitine administered prior to radiation therapy reduces the severity of radiation induced oral mucositis pain in patients who have been diagnosed with nasopharyngeal carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Induced Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lappaconitine Adhesive Patch | Drug | — | UNRESOLVED |
| standard care | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Lappaconitine Adhesive Patch Lappaconitine Adhesive Patch is administered every radiation day, until the end of radiotherapy.
- interventionNames
- Drug: Lappaconitine Adhesive Patch
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Patients will be given standard care when oral pain is reported
- interventionNames
- Drug: standard care
Primary outcomes (1)
- measure
- Change from Baseline Numeric Rating Scale for Pain(NRS scale) at 7 weeks
- timeFrame
- The NRS scale will be assessed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Newly histologic diagnosis of nasopharyngeal carcinoma without distant metastasis * Clinical stage III\~IVa( UICC (Union International Against Cancer) /AJCC (American Joint Committee on Cancer) TNM staging system 8th edition) * Karnofsky Performance Status Scale between 60-100 * WBC count ≥ 4×109/L，neutrophil differential count≥ 1.5×109/L,Hemoglobin ≥ 90g/L， platelet count ≥ 100×109/L * ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN,Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min * Sign the informed consent. Exclusion Criteria: * Younger than 18 years old or older than 70 years old * Pregnancy or lactation * Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes * Have suffered from other tumor or now suffering from other tumor * Have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases * Refuse to give up smoking/drinking/betel chewing * suffering from other active infection diseases and in need of treatment.
References
Publications (0)
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