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

NCT07327216 | Recruiting Phase 3 DMC

• 1 other identifier: PJKT2022-066
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

Nasopharyngeal carcinoma; radiation-induced oral mucositis; Sapylin; Dexamethasone; atomized inhalation

Outcome Measures

Primary Outcomes (2)

• Incidence of Radiation-Induced Oral Mucositis (RIOM)

  Incidence of RIOM is defined as the number of participants developing oral mucositis of any grade. Assessment is based on the World Health Organization (WHO) Oral Toxicity Scale. Scores range from 0 to 4 for ulceration, where higher scores indicate worse outcome.

  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)

  To compare the severity of RlOM between the Sapylin and Dexamethasone groups using the World Health Organization (WHO) Oral Toxicity Scale. Scores range from 0 to 4 for ulceration, where higher scores indicate worse outcome.

  From Week 1 of Concurrent Chemoradiotherapy (CCRT) until the end of Radiotherapy (Week 7).

Secondary Outcomes (4)

• Duration of Radiation-Induced Oral Mucositis (RIOM)

  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

  Measured at the end of the concurrent chemoradiotherapy (CCRT) regimen (Week 7).

• Incidence and Severity of Adverse Events (AEs)

  Daily recording during treatment; Follow-up every 3 months for one year after treatment completion.

• Change in Body Mass Index (BMI)

  Baseline (before CCRT starts) and at the end of treatment (End of Radiotherapy, approximately Week 7).

Study Arms (2)

Sapylin Group

EXPERIMENTAL

CCRT combined with Sapylin atomized inhalation (1 KE/time, QD from day 1 till the end of radiotherapy).

Drug: Sapylin; Combination Product: CCRT with Cisplatin

Dexamethasone Group

ACTIVE COMPARATOR

CCRT combined with Dexamethasone atomized inhalation (10 mg/time, QD from day 1 till the end of radiotherapy).

Drug: Dexamethasone; Combination Product: CCRT with Cisplatin

Interventions

Sapylin DRUG

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

Sapylin Group

Dexamethasone DRUG

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

Dexamethasone Group

CCRT with Cisplatin COMBINATION_PRODUCT

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.

Dexamethasone Group; Sapylin Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Guangdong Medical University: lead

Study Sites (1)

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

streptococcal preparation 722; Dexamethasone; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Haiqing Luo

  Specialty of Head and Neck Oncology, Affiliated Hospital of Guangdong Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiqing Luo, PhD

CONTACT

+8613729196345; hqluo@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 8, 2026
• Study Start: August 15, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after the study publication, extending for 3 years.
• Access Criteria: Any investigator who submits a methodologically sound proposal will be granted access. The data will be de-identified individual participant data, and the purpose must be for scientific research.

Locations

CN (1)