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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
Placebo oral liquid and mouthwash with the same color, aroma, and taste as the experimental group, and without any related drug ingredients
Oral administration of Zishui Daohuo oral liquid combined with gargling using Kujiu mouthwash.
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.
West China Hospital
Chengdu, Sichuan, China
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.
Time frame: 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 severe oral mucositis (RTOG grade≥3)
Time from the first day of radiotherapy to the first determination of SOM.
Time frame: 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)
The first determination of OM to the first instance of non-OM, without a subsequent instance of OM.
Time frame: 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.
Time frame: 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.
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Time frame: 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
Time frame: From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks.