Radiotherapy-induced Oral Mucositis
Conditions
Brief summary
Evaluate the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.
Detailed description
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.
Interventions
DRUGPlacebo oral liquid and mouthwash
Placebo oral liquid and mouthwash with the same color, aroma, and taste as the experimental group, and without any related drug ingredients
DRUGZishui Daohuo oral liquid combined with Kujiu mouthwash
Oral administration of Zishui Daohuo oral liquid combined with gargling using Kujiu mouthwash.
RADIATIONRadiotherapy
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.
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 |
|---|---|---|
| The duration of severe oral mucositis (RTOG grade≥3) | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 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 |
|---|---|---|
| The time to onset of severe oral mucositis (RTOG grade≥3) | 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 SOM. |
| The duration 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. | The first determination of OM to the first instance of non-OM, without a subsequent instance of OM. |
| 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. |
| Relief rate of oral mucositis | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. | The proportion of patients whose oral mucositis resolved to RTOG grade 0 at 4 and 8 weeks after completion of radiotherapy. |
| 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
PRINCIPAL_INVESTIGATORXingchen Peng, Professor
West China Hospital
Outcome results
None listed