Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.

Официальное название

Chinese Herbal Oral Solution and Mouthwash Shorten the Duration of Severe Radiotherapy-induced Oral Mucositis in Patients With Head and Neck Malignancies.

Обзор

Evaluate the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.

Подробное описание

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.

Вмешательства

• Препарат Placebo 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
• Препарат Zishui Daohuo oral liquid combined with Kujiu mouthwash
  Oral administration of Zishui Daohuo oral liquid combined with gargling using Kujiu mouthwash.
• Лучевая терапия Radiotherapy
  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.

Первичные конечные точки

• The duration of severe oral mucositis (RTOG grade≥3) [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.]

Вторичные конечные точки (5)

• The time to onset of severe oral mucositis (RTOG grade≥3) [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.]
• The duration 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.]
• 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.]
• Relief rate of oral mucositis [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: NCT07339774 · 2024(1774)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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