Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.
The aim of this clinical trial is to evaluate the efficacy and safety of combining a traditional Chinese medicine (TCM) oral solution with a mouthwash in reducing the duration of severe radiation-induced oral mucositis (RIOM). The study addresses two primary questions: (1) whether the combined use of the TCM oral solution and mouthwash can effectively shorten the duration of severe RIOM, and (2) whether their use is associated with adverse events in patients undergoing radiotherapy.
Participants will initiate treatment on the first day they develop severe RIOM (RTOG grade ≥3) during radiotherapy. They will take Zishui Daohuo oral solution three times daily and use Kuju gargling solution six times daily, or matched placebos. Treatment will continue until two weeks after completion of radiotherapy. After each administration, patients must refrain from eating, drinking, or performing oral hygiene for at least one hour to maximize mucosal contact time.
The trial will compare the intervention group with the placebo group to determine the potential benefits of the combined regimen in improving RIOM.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zishui Daohuo oral liquid combined with Kujiu mouthwash group. | Experimental |
| |
| Placebo oral liquid and mouthwash | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo oral liquid and mouthwash | Drug | Placebo oral liquid and mouthwash with the same color, aroma, and taste as the experimental group, and without any related drug ingredients |
| Measure | Description | Time Frame |
|---|---|---|
| The duration 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 completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The time to onset of severe oral mucositis (RTOG grade≥3) | Time from the first day of radiotherapy to the first determination of SOM. | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. |
| The duration of any-grade oral mucositis (OM) |
| 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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingchen Peng Professor | Contact | +8618980606753 | pxx2014@163.com | |
| JiaYi Yu Doctor | Contact | yujiayi2209@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xingchen Peng, Professor | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| Zishui Daohuo oral liquid combined with Kujiu mouthwash | Drug | Oral administration of Zishui Daohuo oral liquid combined with gargling using Kujiu mouthwash. |
|
| Radiotherapy | Radiation | One of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy. |
|
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. |
| 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. |
| Relief rate of oral mucositis | The proportion of patients whose oral mucositis resolved to RTOG grade 0 at 4 and 8 weeks after completion of radiotherapy. | 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. | 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. |
| 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. |
| 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 |
Not provided
Not provided