Clinical trial · Interventional
Sodium Bicarbonate for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma.
A Prospective, Single-Center, Randomized Controlled Study on Sodium Bicarbonate Mouthwash for the Prevention and Treatment of Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma.
NCT06854510CI-TRIAL-00119712active not recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To evaluate whether the use of 2.5% sodium bicarbonate mouthwash throughout the entire course of radiotherapy for nasopharyngeal carcinoma reduces the severity of radiation-induced oral mucositis and improves patient adherence to treatment.
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 |
|---|---|---|---|
| Nasopharyngeal Cancinoma (NPC) | Nasopharyngeal Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gargle with 0.9% sodium chloride solution during radiotherapy | Drug | — | UNRESOLVED |
| Gargle with 2.5% sodium bicarbonate solution during radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sodium Bicarbonate Solution Gargle Group
- description
- Oral rinses using 2.5% sodium bicarbonate solution were administered daily throughout the radiotherapy course
- interventionNames
- Drug: Gargle with 2.5% sodium bicarbonate solution during radiotherapy
- type
- PLACEBO_COMPARATOR
- label
- Sodium Chloride Solution Gargle Group
- description
- Oral rinses using 0.9% sodium chloride solution were administered daily throughout the radiotherapy course
- interventionNames
- Drug: Gargle with 0.9% sodium chloride solution during radiotherapy
Primary outcomes (1)
- measure
- The incidence of grade ≥2 oral mucositis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically confirmed nasopharyngeal carcinoma. 2. No evidence of distant metastasis (M0). 3. Scheduled to receive radical radiotherapy. 4. Karnofsky scale (KPS) \> 70. 5. Age 18-70 years. 6. Capacity for independent oral rinse administration without dysphagia. Exclusion Criteria: 1. Patients receiving non-platinum-based concurrent chemotherapy regimens. 2. Radiation fields encompassing level Ib lymph nodes. 3. History of pre-existing oral mucosal disorders or recurrent oral ulceration. 4. Prior radiotherapy history. 5. Severe coexisting illness. 6. Pregnancy or lactation.
References
Publications (0)
Data not yet available
No reference posted for this study.