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RecruitingNCT07327216Updated Mar 4, 2026

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

A Phase 3 interventional study of Sapylin and Dexamethasone in Nasopharyngeal Carcinoma (NPC), sponsored by Affiliated Hospital of Guangdong Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-04.

Sponsored by Affiliated Hospital of Guangdong Medical University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Registered 3 years 3 months after the study started (first participant enrolled Aug 2022, registered Dec 2025).
  • Started Aug 2022; still recruiting 4 years 1 month later.
Phase
Phase 3
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nasopharyngeal Carcinoma (NPC)

Keywords

  • Nasopharyngeal carcinoma
  • radiation-induced oral mucositis
  • Sapylin
  • Dexamethasone
  • atomized inhalation
03

In context

Nasopharyngeal Carcinoma

816 studies on the registry are indexed under Nasopharyngeal Carcinoma; 282 are open to participants now.

This study's planned enrollment of 180 is above the median of 84 across 668 interventional studies indexed under Nasopharyngeal Carcinoma.

Browse Nasopharyngeal Carcinoma studies →

Lead sponsor

Affiliated Hospital of Guangdong Medical University is the lead sponsor of 11 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Sapylin Group

    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

  • Active comparator
    Dexamethasone Group

    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

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From the start of Concurrent Chemoradiotherapy (CCRT) through the completion of radiotherapy, assessed weekly for approximately 7 weeks.

  2. 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.

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

Secondary outcomes

  1. Duration of Radiation-Induced Oral Mucositis (RIOM)

    Time from the first diagnosis of RIOM (any grade) until the symptoms resolve to Grade 0 or return to baseline level.

    Time frame: Daily assessment during CCRT, and up to 1 month after the completion of treatment (assessed up to 3 months).

  2. Rate of Completion of Treatment Measures

    Determined by comparing the actual dose and cycle count of Concurrent Chemoradiotherapy (CCRT) administered versus the planned total treatment regimen. Includes: 1) Actual dose divided by planned total dose (%); 2) Actual completed cycles divided by planned total cycles (%).

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

  3. Incidence and Severity of Adverse Events (AEs)

    All observed adverse events will be recorded and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

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

  4. Change in Body Mass Index (BMI)

    Change is defined as the difference between BMI (kg/m2) at the end of treatment and baseline BMI (Baseline BMI: before CCRT starts).

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

07

Study locations

1 of 1 sites recruiting
  • Affiliated Hospital of Guangdong Medical University
    Zhanjiang, Guangdong, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 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. PubMed 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. PubMed 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. PubMed 31177394 ↗

Study documents

  • Study protocol · Jul 27, 2022
  • Protocol and informed consent form · Jul 26, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results will be shared after study completion and publication.Data will be de-identified to protect participant privacy.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07327216
Lead sponsor
Affiliated Hospital of Guangdong Medical University
Responsible party
Sponsor
First posted
Jan 8, 2026
Start date
Aug 15, 2022
Primary completion
Jul 1, 2026 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Mar 4, 2026

Study contacts

Haiqing Luo, PhD
Contact
hqluo@126.com
+8613729196345
Haiqing Luo
principal investigator · Specialty of Head and Neck Oncology, Affiliated Hospital of Guangdong Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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