Набор скоро начнётся NCT07252557

Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy

Без фазы С лечением Head and Neck Cancer (H&Amp;Amp;N) Radiation-induced Oral Mucositis Supportive Care Nursing Interventions

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Water Rinse at Different Temperatures.
Кому может быть актуально: Состояния в реестре: Head and Neck Cancer (H&Amp;Amp;N), Radiation-induced Oral Mucositis, Supportive Care, Nursing Interventions. Базовые параметры: 20 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Тайвань
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effectiveness of Different Mouthwash Temperatures on Oral Mucositis Pain and Patient Comfort During Radiotherapy for Head and Neck Cancer: A Randomized Controlled Trial

Обзор

This single-center randomized controlled trial evaluates the effects of cold (15-20°C) versus room-temperature (30-35°C) water gargling on oral mucositis severity, pain, and comfort in patients with head and neck cancer undergoing radiotherapy. Participants will rinse their mouth four times daily for 30-60 seconds over a 6-week radiotherapy course, with follow-up for two additional weeks. The study hypothesizes that cold-water rinsing can reduce the severity of radiation-induced oral mucositis (RTOM) and pain, improve oral comfort, and minimize treatment interruptions.

Подробное описание

Radiation-induced oral mucositis (RTOM) is a frequent and debilitating side effect of radiotherapy for head and neck cancer, leading to pain, nutritional compromise, and potential treatment discontinuation. Cryotherapy and local temperature modulation have been proposed as low-cost, accessible nursing interventions that reduce inflammation through vasoconstriction and analgesia. This randomized trial will assess the clinical efficacy and patient acceptability of temperature-modulated water rinsing as a non-pharmacologic, supportive-care intervention. Subgroup analyses will examine differential responses among patients with dental sensitivity or betel-nut chewing habits.

Вмешательства

Поведенческое Water Rinse at Different Temperatures
rinse their mouth with cold water at approximately 15-20°C

Первичные конечные точки

Oral Mucositis Severity [Срок оценки: Baseline (prior to radiotherapy), Week 2, Week 4, Week 6 (end of radiotherapy), and 2 weeks after completion of radiotherapy]
Pain Intensity (VAS 0-10) [Срок оценки: Baseline (prior to radiotherapy), Weeks 1-6 during radiotherapy, and 2 weeks after completion of radiotherapy]

Вторичные конечные точки (3)

Oral Comfort [Срок оценки: Baseline, Week 2, Week 4, Week 6 (end of radiotherapy)]
Satisfaction with Rinsing Modality [Срок оценки: Week 6 (end of radiotherapy) and 2 weeks after completion of radiotherapy]
Psychological Distress [Срок оценки: Baseline (prior to radiotherapy) and Week 6 (end of radiotherapy)]

Критерии участия

Критерии включения

Histologically confirmed head and neck cancer (HNC) receiving radiotherapy for the first time, with or without concurrent chemotherapy.
Conscious, communicative, and able to perform the rinsing procedure and complete questionnaires.
Provided written informed consent prior to enrollment.