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Nasopharyngeal Cancinoma (NPC)Phase 3NCT07311772

Prevention and Treatment of Radiation-Induced Oral Mucositis in NPC With Houyanqing Oral Liquid

A Phase 3 study testing Houyanqing Oral Liquid and Conventional Treatment for Radiation-Induced Oral Mucositis in people with Nasopharyngeal Cancinoma (NPC) and Radiation-induced Oral Mucositis, run by Sun Yat-sen University at 16 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Houyanqing Oral Liquid and Conventional Treatment for Radiation-Induced Oral Mucositis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
386 participants
Where
16 sitesChina
Study dates
16 Dec 2025to 15 Aug 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • Pregnant women or lactating women;
  • Patients with severe mental illnesses;
  • Patients with severe cardio-cerebrovascular diseases, endocrine disorders, infectious diseases, or other tumors.

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ming-Yuan Chen, MD, PhD contact

86-13903052650

chmingy@mail.sysu.edu.cn

Yan-Rou Xie, MD contact

86-13751762936

292352606@qq.com

16 sites in 1 country

China16 sites, 16 recruiting

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100021

    Jun-Ling Yi, PhD., +86 13661217998, yijunlin1969@163.com

    Recruiting

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

    Yu-Xiang He, 86-13786112914

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Ya-Qian Han, 86-18673176667

    Recruiting

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213003

    Wen-Dong Gu, 86-13861220022

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Lei Liu, 86-18980606231

    Recruiting

  • Fujian Medical University Cancer Hospital

    Fuzhou, Fujian, 350014

    Sufang Qiu, 86-13609589163

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Pei-Yu Huang, MD, 86-18928013516

    Recruiting

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University

    Guangzhou, Guangdong, 510095

    Bin Qi, 86-13580580985

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhengjiang, 310022

    Feng Jiang, 86-13858065192

    Recruiting

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

    Zhi-Qiang Wang, 86-15887085161

    Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

    Ji-Yong Qin, 86-13808757779

    Recruiting

  • Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Song Qu, 86-13607887386

    Recruiting

  • Eye & ENT Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200031

    Xiao-Shen Wang, 86-18917785187

    Recruiting

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515041

    Kai Chen, 86-13005222990

    Recruiting

  • Wuzhou Red Cross Hospital

    Wuzhou, Guangxi, 543002

    Jin-Hui Liang, 86-13878480806

    Recruiting

  • Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong, 519000

    Ming-Yuan Chen, PhD., 86-13903052650, chmingy@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Randomized Controlled Study of Houyanqing Oral Liquid Combined With Conventional Treatment Versus Conventional Treatment Alone for Preventing and Treating Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma

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.

Read the detailed description

Nasopharyngeal carcinoma (NPC) is a highly prevalent malignant tumor in China. Radical radiotherapy serves as its core treatment modality, yet radiation-induced oral mucositis (RIOM) is the most common adverse reaction of radiotherapy, with an incidence rate as high as 85%-100%, among which 34% of patients develop grade 3-4 mucositis. RIOM can cause oral pain, ulcers, and dysphagia, which not only severely reduce patients' quality of life but also may lead to radiotherapy interruption, increased infection risk, and elevated treatment costs. Therefore, the prevention and treatment of RIOM are of great significance.

At present, conventional clinical prevention and treatment methods include oral hygiene maintenance, epithelial repair-promoting drugs (e.g., recombinant human epidermal growth factor spray, sodium aescinate for injection), and symptomatic supportive care, but there is no universally recognized standard regimen. Houyanqing Oral Liquid is a traditional Chinese medicine preparation composed of Achyranthes aspera L., Kalimeris indica (L.) Sch.-Bip., Plantago asiatica L., and Carpesium abrotanoides L. It possesses the effects of clearing heat and detoxifying, relieving sore throat and pain. Previous studies have confirmed that it exhibits significant efficacy in anti-inflammation, bacteriostasis, and mucosal injury repair, which can shorten the course of oral ulcers and reduce the recurrence rate.

This study intends to conduct a randomized controlled clinical trial to compare the efficacy of Houyanqing Oral Liquid combined with conventional treatment versus conventional treatment alone in preventing RIOM in NPC patients. It aims to verify the advantages of the combined regimen in reducing the incidence of ≥ grade II RIOM, delaying the onset time, alleviating the severity of injury, and improving patients' quality of life, so as to provide a more effective and safe prevention and treatment strategy for RIOM in clinical practice.

Being tested
Houyanqing Oral Liquid, Conventional Treatment for Radiation-Induced Oral Mucositis
Keywords
Nasopharyngeal Cancinoma, Radiation-induced Oral Mucositis, Houyanqing Oral Liquid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT07311772
Study groupRoleWhat they receive
Houyanqing Oral Liquid combined with Conventional TreatmentExperimentalThis 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.
Receives: Drug: Houyanqing Oral Liquid; Other: Conventional Treatment for Radiation-Induced Oral Mucositis
Conventional TreatmentActive comparatorThis 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.
Receives: Other: Conventional Treatment for Radiation-Induced Oral Mucositis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

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

    Time from the first day of radiotherapy to the first occurrence of Grade II or above radiation-induced oral mucositis according to RTOG/EORTC criteria.

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

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

    Cumulative radiotherapy dose from the first day of radiotherapy to the first occurrence of Grade II or above radiation-induced oral mucositis according to RTOG/EORTC criteria.

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

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

    The proportion of patients who experience remission from Grade II or above to below Grade II radiation-induced oral mucositis after the first occurrence.

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

  4. Complete remission rate of radiation-induced oral mucositis

    The proportion of patients who achieve complete remission of Grade II or above radiation-induced oral mucositis after the first occurrence.

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

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

    Time from the first occurrence of Grade II or above radiation-induced oral mucositis to remission below Grade II.

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

  6. Complete remission time of radiation-induced oral mucositis

    Time from the first occurrence of Grade II or above radiation-induced oral mucositis to complete remission.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2025
  2. Study start16 Dec 2025
  3. Primary completion15 Mar 2027 (estimated)
  4. Study completion15 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
386 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07311772
Sponsor's protocol ID
ZDWY-CMY-Houyanqing OL
Status last verified
May 2026
First submitted
11 Dec 2025
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Houyanqing Oral Liquid and Conventional Treatment for Radiation-Induced Oral Mucositis in people with Nasopharyngeal Cancinoma (NPC) and Radiation-induced Oral Mucositis, run by Sun Yat-sen University at 16 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ming-Yuan Chen, MD, PhD (86-13903052650, chmingy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of ≥ Grade II radiation-induced oral mucositis (time frame: From the start of radical radiotherapy to the 3 months after the completion of radiotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07311772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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