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Evaluate the efficacy and safety of traditional Chinese medicine oral liquid and mouthwash in the treatment of radiotherapy induced oral mucositis in patients with head and neck malignancies
The aim of this clinical trial is to evaluate the efficacy and safety of combining a traditional Chinese medicine (TCM) oral liquid with a mouthwash in reducing the incidence, duration, and severity of mild-to-moderate radiation-induced oral mucositis (RIOM). The study addresses two main questions: (1) whether the combined TCM oral liquid and mouthwash can effectively mitigate RIOM and lower the incidence of severe RIOM, and (2) whether their use is associated with adverse events in patients receiving radiotherapy.
Participants will begin treatment on the first day mild-to-moderate RIOM (RTOG grade 1-2) occurs during radiotherapy. They will take Qingying oral liquid four times daily and use a modified Da Huang-Huang Lian Xiexin mouthwash six times daily in combination, or receive a matching placebo. The treatment will continue until two weeks after radiotherapy. After each administration, patients must avoid eating, drinking, or performing oral hygiene for at least 1 hour to maximize mucosal contact time.
The trial will compare the intervention and placebo groups to determine the potential benefits of the combined regimen for managing RIOM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash | Active Comparator |
| |
| Placebo oral solution and mouthwash | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash | Drug | Classical traditional Chinese medicine (TCM) formulations provided as an oral liquid and a herbal mouthwash |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of severe oral mucositis (RTOG grade ≥ 3) | The Radiation Therapy Oncology Group (RTOG) toxicity criteria were utilized to assess RIOM. Grade 0 shows no change from baseline; Grade 1 of RIOM is associated with mucosal erythema or hyperemiam,and may cause mild pain not requiring analgesics. Grade 2 presents with patchy mucositis that may produce an inflammatory serosanguinous discharge and may be associated with moderate pain; Grade 3 consists of confluent, fibrinous mucositis and may include severe pain requiring narcotics; Grade 4 is characterized by ulceration, hemorrhage, or necrosis. Grades 1 and 2 are considered mild to moderate, while grades 3 and 4 are classified as severe. | From the start of radiotherapy to 8 weeks after the end of radiotherapy. The evaluation period is approximately 14 to 14.5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of mild-to-moderate RIOM | Time from the first documentation of RTOG grade 1-2 oral mucositis during radiotherapy to the first return to RTOG grade 0 (no mucositis) sustained for ≥48 hours. | From the start of radiotherapy to 8 weeks after the end of radiotherapy. The evaluation period is approximately 14 weeks and 14.5 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The longitudinal dynamics of salivary microbiota | Unstimulated whole saliva samples will be collected via spitting method at three time points: baseline, mid-term radiotherapy (the week corresponding to 50% completion of the planned radiation fractions), and the end of radiotherapy (the final week of RT). 16S rRNA gene sequencing will be performed to assess alterations in the oral microbiota. | 1 week before radiotherapy, the middle of radiotherapy (3 weeks after the start of radiotherapy), and the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingchen Peng, Professor | Contact | +8618980606753 | pxx2014@163.com | |
| Jiayi Yu, Doctor | Contact | +8618349376247 | yujiayi2209@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Placebo oral solution and mouthwash | Drug | A placebo matched in color, odor, and taste to the Qingying oral liquid and the modified Da Huang-Huang Lian Xiexin mouthwash, but containing no active medicinal ingredients. |
|
| radiotherapy | Radiation | All subjects underwent radical radiotherapy |
|
| The time to onset of any-grade oral mucositis (OM) |
Time from the first day of radiotherapy to the first determination of OM. |
| From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. |
| RIOM remission rates at 4 and 8 weeks after completion of radiotherapy | The proportion of participants whose oral mucositis has decreased to RTOG grade 0 at 4 and 8 weeks after completion of radiotherapy, respectively. | From the start of radiotherapy to 8 weeks after the end of radiotherapy. The evaluation period is approximately 14 weeks and 14.5 weeks. |
| Duration of oral mucositis (OM) | The first determination of OM to the first instance of non-OM, without a subsequent instance of OM. | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. |
| Adverse events | Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version | From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks. |
| Analysis of Inflammatory Indicators in Oral Saliva | Measurement of circulating levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) in patient oral saliva. | 1 week before radiotherapy, the middle of radiotherapy (3 weeks after the start of radiotherapy), and the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks). |
| Mouth and throat soreness (MTS) scores | Patients report mouth and throat soreness (MTS) scores (Likert scale 1 to 5) via the oral mucositis weekly questionnaire (OMWQ). Higher score indicates more severe symptoms. | The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks. |
| Oral activities scores | Patients report the degree to the impact of MTS on oral activities (including swallowing, drinking, eating, talking, sleeping) (Likert scale 1 to 5) via the oral mucositis weekly questionnaire (OMWQ). Higher score indicates more severe symptoms. | The time period is the period from the start of radiotherapy to the completion of radiotherapy. The evaluation period is approximately 6 weeks and 6.5 weeks. |
| TCM syndrome score for RIOM | The Radiation-Induced Oral Mucositis Symptom Score Scale is a 17-item patient-reported outcome measure assessing the severity of radiotherapy-related oral mucositis symptoms. The scale covers both oral local manifestations and systemic discomforts. Each item is rated on a 4-point Likert scale (0-3) corresponding to no, mild, moderate, and severe symptoms, respectively. The total score is calculated by summing the scores of all items. Higher total scores indicate greater symptom severity and a heavier symptom burden, whereas lower scores reflect milder symptoms or better symptom relief. | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. |
| Overall Health Status and Core Dimensions of Quality of Life | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) This instrument is a 30-item patient-reported outcome (PRO) measure designed to evaluate core aspects of health-related quality of life in cancer patients, including 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, pain, nausea and vomiting), one global health status/quality of life scale, and 6 single-item symptom measures. Scores are linearly transformed to a range of 0-100. For the functional scales and the global health status scale, higher scores indicate better functional levels or quality of life; for the symptom scales/items, higher scores indicate greater symptom burden. | From the start of radiotherapy (baseline) to 2 months after treatment completion. The total evaluation period is approximately 14 to 14.5 weeks |
| Head and Neck Cancer-Specific Symptoms | The EORTC QLQ-H&N35 is a patient-reported outcome (PRO) instrument specifically designed to assess disease-related symptoms and treatment-related side effects in patients with head and neck cancer. It comprises 35 items, organized into seven multi-item subscales (pain, swallowing, senses, speech, social eating, social contact, and sexuality) and eleven single-item measures (such as dental problems, problems opening mouth, sticky saliva, coughing, etc.). All subscale and single-item scores are linearly transformed to a 0-100 scale using a standardized scoring algorithm. Interpretation of Scores: For all subscales and single items, higher scores represent more severe symptoms or greater symptom burden. | From the start of radiotherapy (baseline) to 2 months after treatment completion. The total evaluation period is approximately 14 to 14.5 weeks. |
| Xerostomia | Xerostomia was graded per CTCAE v5.0 (Grade 1-4), with higher grades indicating worse symptoms. | 1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks); and 1, 3 months after the end of radiotherapy. |
| ID | Term |
|---|---|
| D009067 | Mouthwashes |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D013812 | Therapeutics |
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