RecruitingPhase 3NCT07327216

Sapylin Versus Dexamethasone Inhalation for CCRT-Induced Oral Mucositis in Nasopharyngeal Carcinoma

Efficacy and Safety of Sapylin Versus Dexamethasone Atomized Inhalation for Concurrent Chemoradiotherapy-Induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma: A Randomized, Parallel, Non-inferiority Clinical Trial


Sponsor

Affiliated Hospital of Guangdong Medical University

Enrollment

180 participants

Start Date

Aug 15, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for mouth sores (oral mucositis) — a painful and common side effect of radiation and chemotherapy for nasopharyngeal cancer (cancer behind the nose). One treatment is Sapylin (a bacterial immune stimulant) and the other is dexamethasone (a steroid), both given as inhalations during treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with stage III or IVa nasopharyngeal cancer confirmed by biopsy - You have not yet received any cancer treatment (no prior radiation, chemo, surgery, or immunotherapy) - Your mouth and gums are in normal, healthy condition before starting treatment - Your blood counts and liver and kidney function are in acceptable ranges **You may NOT be eligible if...** - You have another current or past cancer, or your cancer has spread to distant organs - You have already undergone surgery, chemoradiation, or targeted/immune therapy - You have a history of allergies such as asthma, rash, or hives - You have autoimmune disease, diabetes that may affect mouth healing, serious heart or kidney disease - You are pregnant, breastfeeding, or planning to become pregnant during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSapylin

Atomized inhalation, 1 KE/time, QD from day 1 of CCRT until the end of radiotherapy.

DRUGDexamethasone

Dexamethasone (10 mg per administration) via atomized inhalation once daily (QD).

COMBINATION_PRODUCTCCRT with Cisplatin

Patients receive cisplatin-based CCRT: cisplatin 80-100mg/m2, Q3W, three times during CCRT. Radiation dose: PTVnx: 69.96Gy/33F, PTV1: 60.06Gy/33F, PTV2: 54.12Gy/33F.


Locations(1)

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

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NCT07327216


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