Radiation-induced Oral Mucositis
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGQingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash
Classical traditional Chinese medicine (TCM) formulations provided as an oral liquid and a herbal mouthwash
DRUGPlacebo oral solution and mouthwash
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.
RADIATIONradiotherapy
All subjects underwent radical radiotherapy
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors; 2. Age range: 18 to 65 years old (including 18 and 65 years old); 3. Eastern Cooperative Oncology Group performance status of ≤2; 4. Radiotherapy or concurrent chemoradiotherapy is required; 5. The main organ functions well; 6. Sign informed consent.
Exclusion criteria
1. Allergic constitution (such as those known to be allergic to two or more drugs); 2. Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the start of radiotherapy; 3. Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study; 4. Poor oral hygiene and/or severe periodontal diseases; 5. History of head and neck radiotherapy; 6. Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of severe oral mucositis (RTOG grade ≥ 3) | From the start of radiotherapy to 8 weeks after the end of radiotherapy. The evaluation period is approximately 14 to 14.5 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of mild-to-moderate RIOM | From the start of radiotherapy to 8 weeks after the end of radiotherapy. The evaluation period is approximately 14 weeks and 14.5 weeks. | 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. |
| The time to onset of any-grade oral mucositis (OM) | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. | Time from the first day of radiotherapy to the first determination of OM. |
| RIOM remission rates at 4 and 8 weeks after completion of radiotherapy | From the start of radiotherapy to 8 weeks after the end of radiotherapy. The evaluation period is approximately 14 weeks and 14.5 weeks. | The proportion of participants whose oral mucositis has decreased to RTOG grade 0 at 4 and 8 weeks after completion of radiotherapy, respectively. |
| Duration of oral mucositis (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 first determination of OM to the first instance of non-OM, without a subsequent instance of OM. |
| Adverse events | From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks. | Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version |
Countries
China
Contacts
CONTACTXingchen Peng, Professor
CONTACTJiayi Yu, Doctor
Outcome results
None listed