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Active Not Recruiting
NCT06854510
Sodium Bicarbonate for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma.
Conditions: Nasopharyngeal Cancinoma (NPC)
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 196
Sponsor: Sun Yat-sen University
Location: Sun Yat-sen University Cancer Center Guangzhou Guangdong
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06854510). StuddyBuddy aggregates publicly available trial information.
