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

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

Overview

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.

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.

Interventions

• Drug Houyanqing Oral Liquid
  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 m
• Other Conventional Treatment for Radiation-Induced Oral Mucositis
  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.

Primary outcome measures

• 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]

Secondary outcome measures (6)

• Time to onset of Grade II or above radiation-induced oral mucositis [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From the first occurrence of Grade II or above radiation-induced oral mucositis to 3 months after the completion of radiotherapy.]
• Complete remission time of radiation-induced oral mucositis [Time frame: From the first occurrence of Grade II or above radiation-induced oral mucositis to 3 months after the completion of radiotherapy.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

China · 16 centers

• Cancer Hospital Chinese Academy of Medical Science — Beijing
• Fujian Medical University Cancer Hospital — Fuzhou
• Sun Yat-sen University Cancer Center — Guangzhou
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University — Guangzhou
• Cancer Hospital of Shantou University Medical College — Shantou
• Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai
• Cancer Hospital of Guangxi Medical University — Nanning
• Wuzhou Red Cross Hospital — Wuzhou
• … and 8 more centers

Identifiers

NCT: NCT07311772 · ZDWY-CMY-Houyanqing OL

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗