NCT06854510 Sodium Bicarbonate for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma.
| NCT ID | NCT06854510 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Nasopharyngeal Cancinoma (NPC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 196 participants |
| Start Date | 2025-02-21 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 196 participants in total. It began in 2025-02-21 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06854510 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Nasopharyngeal Cancinoma (NPC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06854510 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06854510 currently recruiting?
Yes, NCT06854510 is actively recruiting participants. Contact the research team at tangll@sysucc.org.cn for enrollment information.
Where is the NCT06854510 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06854510 clinical trial?
NCT06854510 is sponsored by Sun Yat-sen University. The trial plans to enroll 196 participants.