Physical Exercise for Patients With Head and Neck Cancer
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: Experimental Intervention.
- Кому может быть актуально
- Состояния в реестре: Head and Neck Cancer. 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
- Нидерланды
- 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
The Effect of Physical Exercise During Radiotherapy on Physical Functioning in Patients With Head and Neck Cancer: a Trial Within Cohorts, the VITAL Study
Обзор
The goal of this trial within cohorts study is to determine and compare physical performance, muscle strength, fatigue, quality of life, body composition, nutritional status, physical activity, treatment tolerability of radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT), and healthcare related costs in patients with head and neck cancer (HNC) with and without a 10 week physical exercise intervention (PEI) during RT, CRT or BRT ((C/B)RT). Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI twice a week for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. Researchers will compare patients who undergo the PEI with patients who did not undergo the PEI to see if there is difference in physical performance, muscle strength, fatigue, Quality of Life, body composition, nutritional status, physical activity, treatment tolerability of (C/B)RT , and healthcare related costs in patients with Head and Neck Cancer (HNC) with and without a 10 week Physical Exercise Intervention (PEI) during (C/B)RT).
Вмешательства
- Другое Experimental Intervention
Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. The PEI consists of a 60 minutes intervention twice a week and will be supervised by a physiotherapist specialized in oncology. Patients who receive the intervention also have to do home-based aerobic and muscle strength exercises by themselves three times a week.
Первичные конечные точки
- physical performance [Срок оценки: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
Вторичные конечные точки (12)
- Muscle strength [Срок оценки: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Muscle strength [Срок оценки: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Muscle strength [Срок оценки: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Health Related Quality of Life [Срок оценки: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Health Related Quality of Life [Срок оценки: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Health Related Quality of Life [Срок оценки: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Fatigue [Срок оценки: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Body composition [Срок оценки: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Nutrition status [Срок оценки: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Physical activity [Срок оценки: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)]
- Tolerability of radiotherapy, chemoradiation or bioradiation [Срок оценки: M1 (12 weeks), M2 (6 months), M3 (12 months)]
- socio-demographic data and medical data [Срок оценки: M0 (baseline/before (C/B)RT)]
Критерии участия
Критерии включения
- patients with HNC who are scheduled for (C/B)RT,
- ≥18 years of age,
- sufficient Dutch writing and reading skills,
- a Karnofsky performance status (KPS) >60,
- able to walk ≥60m without a mobility aid, and
- no contraindication for physical activity as measured with the physical activity readiness questionnaire (PAR-Q).
Критерии исключения
- recurrence of HNC and/or
- secondary HNC.
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
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
Нидерланды · 1 центр
- Instituut Verbeeten — Tilburg
Публикации
- Kriellaars Y, Vermaire JA, Beugeling M, Poorter R, Drijvers J, Speksnijder CM. The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer: a trial within cohorts study protocol, the vital study. BMC Cancer. 2024 Apr 1;24(1):403. doi: 10.1186/s12885-024-12172-2. PMID 38561708
Идентификаторы
NCT: NCT05988060 · NL79549.028.21