NCT07311772

Brief Summary

To explore the efficacy of Houyanqing Oral Liquid combined with conventional treatment in preventing and treating radiation-induced oral mucositis, so as to improve the quality of life of nasopharyngeal carcinoma patients received radiotherapy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P50-P75 for phase_3

Timeline
15mo left

Started Dec 2025

Geographic Reach
1 country

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Dec 2025Aug 2027

First Submitted

Initial submission to the registry

December 11, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2027

Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

1.2 years

First QC Date

December 11, 2025

Last Update Submit

December 29, 2025

Conditions

Nasopharyngeal Cancinoma (NPC)Radiation-induced Oral Mucositis

Keywords

Nasopharyngeal CancinomaRadiation-induced Oral MucositisHouyanqing Oral Liquid

Outcome Measures

Primary Outcomes (1)

  • Incidence of ≥ Grade II radiation-induced oral mucositis

    The proportion of patients in the group who develop Grade II or above radiation-induced oral mucositis from the start of radiotherapy. The degree of oral mucosal damage is evaluated according to the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) diagnostic and grading criteria for radiation-induced oral mucositis.

    From the start of radical radiotherapy to the 3 months after the completion of radiotherapy

Secondary Outcomes (6)

  • Time to onset of Grade II or above radiation-induced oral mucositis

    From the start of radical radiotherapy to the 3 months after the completion of radiotherapy.

  • Cumulative radiotherapy dose at onset of Grade II or above radiation-induced oral mucositis

    From the start of radical radiotherapy to the 3 months after the completion of radiotherapy.

  • Remission rate of Grade II or above radiation-induced oral mucositis

    From the first occurrence of Grade II or above radiation-induced oral mucositis to 3 months after the completion of radiotherapy

  • Complete remission rate of radiation-induced oral mucositis

    From the first occurrence of Grade II or above radiation-induced oral mucositis to 3 months after the completion of radiotherapy

  • Remission time of Grade II or above radiation-induced oral mucositis

    From the first occurrence of Grade II or above radiation-induced oral mucositis to 3 months after the completion of radiotherapy.

  • +1 more secondary outcomes

Study Arms (2)

Houyanqing Oral Liquid combined with Conventional Treatment

EXPERIMENTAL

This arm involves Houyanqing Oral Liquid combined with conventional treatment for preventing radiation-induced oral mucositis (RIOM) in nasopharyngeal carcinoma patients receiving radical radiotherapy. Specific interventions include: 1) Houyanqing Oral Liquid administration before and during radiotherapy; 2) Conventional treatment (same as the control arm): oral hygiene management, epithelial repair promotion, and symptomatic support therapy; 3) Radical radiotherapy (conventional fractionation). The aim is to evaluate the effect of this combined regimen on reducing RIOM severity.

Drug: Houyanqing Oral LiquidOther: Conventional Treatment for Radiation-Induced Oral Mucositis

Conventional Treatment

ACTIVE COMPARATOR

This arm consists of conventional treatment for preventing radiation-induced oral mucositis (RIOM) in nasopharyngeal carcinoma patients undergoing radical radiotherapy. Specific interventions include: 1) Oral hygiene management; 2) Epithelial repair promotion; 3) Symptomatic support . Patients in this arm will receive radical radiotherapy (conventional fractionation) but will not be administered Houyanqing Oral Liquid.

Other: Conventional Treatment for Radiation-Induced Oral Mucositis

Interventions

Conventional Treatment for Radiation-Induced Oral MucositisOTHER

This intervention refers to the conventional management measures for radiation-induced oral mucositis (RIOM) in nasopharyngeal carcinoma patients undergoing radical radiotherapy, including three modules: 1) Oral hygiene management; 2) Epithelial repair promotion; 3) Symptomatic support. These measures are implemented throughout the radiotherapy period to alleviate RIOM-related symptoms.

Conventional TreatmentHouyanqing Oral Liquid combined with Conventional Treatment
Houyanqing Oral LiquidDRUG

Houyanqing Oral Liquid is a Chinese herbal preparation formulated with Achyranthes aspera L., Kalimeris indica (L.) Sch.-Bip., Plantago asiatica L., and Carpesium abrotanoides L.. For this study, it is used in nasopharyngeal carcinoma patients receiving radical radiotherapy: the dosage is 10mL per administration, 4 times daily. The medication is initiated prior to radiotherapy and continued until the completion of radiotherapy, with the purpose of preventing and treating radiation-induced oral mucositis.

Houyanqing Oral Liquid combined with Conventional Treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Staged as Stage I-IV according to the 9th edition of the TNM Classification of Malignant Tumors formulated by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC);
  • Age: 18 to 75 years old;
  • Karnofsky Performance Status (KPS) score ≥ 80 before treatment;
  • No oral diseases (such as oral mucositis or salivary gland damage) before radiotherapy;
  • Requiring radical radiotherapy;
  • The patient has signed the informed consent form and is willing and able to comply with the study's follow-up visits, treatment plan, laboratory tests, and other research procedures.

You may not qualify if:

  • Patients with confirmed tumor recurrence, distant tumor metastasis, or who have received other anti-tumor treatments;
  • Previous history of head and neck radiotherapy;
  • Known allergy to the drugs used in this study (Houyanqing Oral Liquid, any conventional treatment drugs);
  • Local use of Houyanqing Oral Liquid, Recombinant Human Epidermal Growth Factor (rhEGF) Topical Solution, Vitamin B12 Solution, or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) mouthwash in the oral cavity within one month before enrollment;
  • Comorbidities requiring long-term treatment with immunosuppressive drugs, or systemic/local use of corticosteroids at immunosuppressive doses before enrollment;
  • HIV-positive patients;
  • Pregnant women or lactating women;
  • Patients with severe mental illnesses;
  • Patients with severe cardio-cerebrovascular diseases, endocrine disorders, infectious diseases, or other tumors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

RECRUITING

Fujian Medical University Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, 510095, China

RECRUITING

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, 515041, China

RECRUITING

Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, 543002, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213003, China

RECRUITING

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhengjiang, 310022, China

RECRUITING

Study Officials

  • Ming-Yuan Chen, MD, PhD

    Fifth Affiliated Hospital of Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Yuan Chen, MD, PhD

CONTACT

86-13903052650chmingy@mail.sysu.edu.cn

Yan-Rou Xie, MD

CONTACT

86-13751762936292352606@qq.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 11, 2025

First Posted

December 31, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

August 15, 2027

Last Updated

December 31, 2025

Record last verified: 2025-12

Locations

CN(16)