Traditional Chinese Medicine Oral Liquids and Mouthwashes for Radiation-induced Oral Mucositis in Head and Neck Cancer Patients

Официальное название

Traditional Chinese Medicine Oral Liquids and Mouthwashes for Radiation-induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Controlled Trial

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Qingying 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
• Препарат Placebo 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.
• Лучевая терапия radiotherapy
  All subjects underwent radical radiotherapy

Первичные конечные точки

• Incidence rate of severe oral mucositis (RTOG grade ≥ 3) [Срок оценки: From the start of radiotherapy to 8 weeks after the end of radiotherapy. The evaluation period is approximately 14 to 14.5 weeks]

Вторичные конечные точки (5)

• Duration of mild-to-moderate RIOM [Срок оценки: 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 time to onset of any-grade oral mucositis (OM) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks.]

Критерии участия

Критерии включения

• Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
• Age range: 18 to 65 years old (including 18 and 65 years old);
• Eastern Cooperative Oncology Group performance status of ≤2;
• Radiotherapy or concurrent chemoradiotherapy is required;
• The main organ functions well;
• Sign informed consent.

Критерии исключения

• Allergic constitution (such as those known to be allergic to two or more drugs);
• 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;
• Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
• Poor oral hygiene and/or severe periodontal diseases;
• History of head and neck radiotherapy;
• Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• West China Hospital — Чэнду

Идентификаторы

NCT: NCT07282483 · 2024-1774

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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