Набор скоро начнётся NCT06407570

Dysphagia and Quality of Life in Patients With Oral Squamous Cell Carcinoma Before and After Treatment

— Наблюдательное Oral Cavity Cancer Dysphagia Quality of Life

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Oral Cavity Cancer, Dysphagia, Quality of Life. Базовые параметры: от 18 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: Дания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

While the group of oral cavity cancer (OCC) survivors continue to increase, surgeons and oncologist intensify their search for improved treatment and rehabilitation methods to reduce the morbidity of management without compromising the oncological safety. The predominant problem after treatment of OCC is dysphagia, which is associated with malnutrition, aspiration pneumonia, hospital re-admission, and reduced quality of life (QoL) and survival. In a pilot study, the investigators found that 45% of OCC patients reported significant eating disabilities two years after surgical treatment. However, the international literature is limited on the dysphagia and QoL of OCC survivors. With an overall goal to improve the QoL and health status in patients treated for OCC, the present study aims to 1. systematically evaluate the swallowing function before and after treatment, 2. investigate the impact of swallowing function on QoL, 3. identify risk factors for dysphagia, 4. investigate if swallowing function is an independent factor for the number of ´days alive and out of hospital´ 5. evaluate the rehabilitation offered to OCC patients in Danish municipalities and the effect on swallowing outcomes. One hundred patients treated for OCC will be included prospectively during a 2-year period. Data on type and location of tumour, treatment modality, complications, patient weight, dietary intake, rehabilitation program, hospital admissions, recurrences, and survival will be collected. Questionnaires and Modified Barium Swallow Study (MBSS) will be performed before and 2 and 12 months after treatment.

Первичные конечные точки

Modified Barium Swallow Impairment profile (MBSImp) [Срок оценки: Baseline, 2 and 12 months post-operative]
MD Anderson Dysphagia Inventory (MDADI) [Срок оценки: Baseline, 2 and 12 months post-operative]
Days alive and out of hospital [Срок оценки: 12 months post-operative]

Вторичные конечные точки (4)

Weight [Срок оценки: Baseline, 2 and 12 months post-operative]
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) [Срок оценки: Baseline, 2 and 12 months post-operative]
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head And Neck 35 (EORTC H&N-35) [Срок оценки: Baseline, 2 and 12 months post-operative]
Functional oral intake score (FOIS) [Срок оценки: Baseline, 2 and 12 months post-operative]

Критерии участия

Критерии включения

Histologically confirmed squamous cell carcinoma with any location in the oral cavity including recurrences. Patients will only be included once
Treatment with curative intent (surgery and/or (chemo)radio therapy)