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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Sapylin
  Atomized inhalation, 1 KE/time, QD from day 1 of CCRT until the end of radiotherapy.
• Препарат Dexamethasone
  Dexamethasone (10 mg per administration) via atomized inhalation once daily (QD).
• Комбинированный продукт CCRT 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.

Первичные конечные точки

• Incidence of Radiation-Induced Oral Mucositis (RIOM) [Срок оценки: From the start of Concurrent Chemoradiotherapy (CCRT) through the completion of radiotherapy, assessed weekly for approximately 7 weeks.]
• Severity of Radiation-Induced Oral Mucositis (RIOM) [Срок оценки: From Week 1 of Concurrent Chemoradiotherapy (CCRT) until the end of Radiotherapy (Week 7).]

Вторичные конечные точки (4)

• Duration of Radiation-Induced Oral Mucositis (RIOM) [Срок оценки: Daily assessment during CCRT, and up to 1 month after the completion of treatment (assessed up to 3 months).]
• Rate of Completion of Treatment Measures [Срок оценки: Measured at the end of the concurrent chemoradiotherapy (CCRT) regimen (Week 7).]
• Incidence and Severity of Adverse Events (AEs) [Срок оценки: Daily recording during treatment; Follow-up every 3 months for one year after treatment completion.]
• Change in Body Mass Index (BMI) [Срок оценки: Baseline (before CCRT starts) and at the end of treatment (End of Radiotherapy, approximately Week 7).]

Критерии участия

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Affiliated Hospital of Guangdong Medical University — Zhanjiang

Публикации

• Peterson DE, Boers-Doets CB, Bensadoun RJ, Herrstedt J; ESMO Guidelines Committee. Management of oral and gastrointestinal mucosal injury: ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v139-51. doi: 10.1093/annonc/mdv202. Epub 2015 Jul 4. No abstract available. PMID 26142468
• Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet. 2019 Jul 6;394(10192):64-80. doi: 10.1016/S0140-6736(19)30956-0. Epub 2019 Jun 6. PMID 31178151
• Kong D, Zhang D, Cui Q, Wang K, Tang J, Liu Z, Wu G. Sapylin (OK-432) alters inflammation and angiogenesis in vivo and vitro. Biomed Pharmacother. 2019 May;113:108706. doi: 10.1016/j.biopha.2019.108706. Epub 2019 Mar 4. PMID 30844656
• Nishii M, Soutome S, Kawakita A, Yutori H, Iwata E, Akashi M, Hasegawa T, Kojima Y, Funahara M, Umeda M, Komori T. Factors associated with severe oral mucositis and candidiasis in patients undergoing radiotherapy for oral and oropharyngeal carcinomas: a retrospective multicenter study of 326 patients. Support Care Cancer. 2020 Mar;28(3):1069-1075. doi: 10.1007/s00520-019-04885-z. Epub 2019 Jun 8. PMID 31177394

Идентификаторы

NCT: NCT07327216 · PJKT2022-066

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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