NCT07327216 Sapylin Versus Dexamethasone Inhalation for CCRT-Induced Oral Mucositis in Nasopharyngeal Carcinoma
| NCT ID | NCT07327216 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Affiliated Hospital of Guangdong Medical University |
| Condition | Nasopharyngeal Carcinoma (NPC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2022-08-15 |
| Primary Completion | 2026-07-01 |
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.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 180 participants in total. It began in 2022-08-15 with a primary completion date of 2026-07-01.
⚠ 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
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, potentially making the CCRT less effective. Studies have shown that a significant number of patients stop treatment early due to this toxicity. Current clinical guidelines from organizations like MASCC/ISOO and ESMO agree that preventing RTOM is crucial, but there is currently no specific drug that works for everyone. This study aims to investigate a new approach: using Sapylin, a biological immune regulator, delivered through an atomized inhaler. Preliminary research suggests Sapylin delivered this way may enhance the effectiveness of chemotherapy and boost the body's immunity. The main purpose of this study is to determine the effect of Sapylin inhalation on the incidence and severity of RTOM, and to evaluate its safety and impact on the overall success of CCRT. By participating, you will help researchers find a high-efficiency, low-toxicity method to improve CCRT outcomes and manage RTOM for future NPC patients and specialists.
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; * Age 18-75 years; * Voluntary participation and provision of informed consent in person; * Routine blood examination: white blood cell count ≥4.0×109/L, hemoglobin ≥100g/L, neutrophil count ≥1.5×10\^9/L, and platelet count ≥100×10\^9/L; * Biochemical examination: total bilirubin ≤1.5×the upper limit of the normal range (ULN), alanine aminotransferase and aspartate aminotransferase ≤2×ULN, and estimated glomerular filtration rate ≥60 mL/min. 2. Exclusion Criteria: * With other malignant tumors in the past or present and/or distant metastasis during treatment; * Who have undergone surgery, chemoradiotherapy, and targeted immunotherapy; * With a history of asthma, rash, urticaria, and other allergic diseases; * With a history of autoimmune diseases, connective tissue diseases, and diabetes mellitus that significantly affect the healing of the oral mucosa; * With concomitant diseases, such as heart disease, kidney disease, and acute infectious diseases, which are judged by the investigator to seriously endanger the safety of patients or affect the completion of the study; * Who are breastfeeding, pregnant, or planning to become pregnant during the study; * With known allergies to the therapeutic agents and penicillin used in the trial; * Mental or nervous system diseases or poor compliance.
Contact & Investigator
Haiqing Luo
PRINCIPAL INVESTIGATOR
Specialty of Head and Neck Oncology, Affiliated Hospital of Guangdong Medical University
Frequently Asked Questions
Who can join the NCT07327216 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Nasopharyngeal Carcinoma (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 NCT07327216 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 180 participants.
Is NCT07327216 currently recruiting?
Yes, NCT07327216 is actively recruiting participants. Contact the research team at hqluo@126.com for enrollment information.
Where is the NCT07327216 trial being conducted?
This trial is being conducted at Zhanjiang, China.
Who is sponsoring the NCT07327216 clinical trial?
NCT07327216 is sponsored by Affiliated Hospital of Guangdong Medical University. The principal investigator is Haiqing Luo at Specialty of Head and Neck Oncology, Affiliated Hospital of Guangdong Medical University. The trial plans to enroll 180 participants.