Improvement of Quality of Life by Cannabinoids in Oncologic Patients
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: Cannabisextrakt Avextra 10/10 Lösung.
- Кому может быть актуально
- Состояния в реестре: Medical Oncology, Palliative Care, Quality of Life, Cannabinoids. Базовые параметры: от 25 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
- Германия
- 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
Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BEfindLichkeitsverbesserung Unter CANnabinoid-ExtrakTen Bei Onkologischen Patienten)
Обзор
The goal is to explore whether the application of cannabis extract Avextra 10/10 solution is suitable to contribute to an improvement in the symptom burden and well-being of oncological palliative care patients. The primary objective of the study is to demonstrate the improvement in global symptom burden in the intervention arm compared to the placebo control group over a period of 12±2 days, as measured by a percentage change in the value of the Edmonton Symptom Assessment System total symptom distress score (ESAS TSDS) at baseline and after 12±2 days.
Подробное описание
170 oncological patients in palliative treatment will be randomized 1:1 to an THC:CBD-interventional arm and an placebo-arm. At the timepoints baseline, 12±2 days, 18±3 days, four weeks and eight weeks, the global burden of symptoms (ESAS TSDS), quality of life (EORTC QLQ C15 PAL) and other parameter will be measured and the intraindividual difference in comparison with the baseline will be compared between the groups. This study is intended to provide a significant contribution to Evidence-based medicine (EbM) of CAM in palliative medicine as well as for elderly and severely ill subjects (resp.) in general.
The following gain of knowledge is expected:
* substancial and reliable effects of CAM in elderly subjects being in a multimorbid and psychologically very stressful situation of illness and life (resp.). * substancial and reliable effects of CAM in aduld subjects being in a oncologically and palliative situation of illness and life (resp.). * compatibility of a CAM-therapy in multimorbid patients with polypharmacotherapy. * importance of CAM for the very frequent psychovegetative disturbance and comorbidities of many illnesses like sleepnesness, loss of appetite, nausea, fear and affective disturbance. * possible reduction of costs and improved economics through CAM
Вмешательства
- Препарат Cannabisextrakt Avextra 10/10 Lösung
medical cannabinoids
Первичные конечные точки
- ESAS-TSDS score [Срок оценки: 12 days]
Вторичные конечные точки (12)
- Global Patient's Assessment [Срок оценки: 12 days, 4 weeks, 8 weeks]
- opioid dose as morphine equivalent [Срок оценки: 12 days, 4 weeks, 8 weeks]
- defined daily dosages (DDD) of neuropharmaceuticals [Срок оценки: 12 days, 4 weeks, 8 weeks]
- ESAS-TSDS score [Срок оценки: 4 weeks, 8 weeks]
- inappetence [Срок оценки: 12 days, 4 weeks, 8 weeks]
- NCCN distress thermometer [Срок оценки: 12 days, 4 weeks, 8 weeks]
- pain as VAS [Срок оценки: 12 days, 4 weeks, 8 weeks]
- sleep quality (Pittsburgh Sleep Quality Index, PSQI) [Срок оценки: 12 days, 4 weeks, 8 weeks]
- EORTC QLQ-C15 PAL [Срок оценки: 12 days, 4 weeks, 8 weeks]
- Adverse events (AE) [Срок оценки: up to 8 weeks]
- C-reactive protein (CRP) [Срок оценки: 12 days, 4 weeks, 8 weeks]
- all endpoints stratified by stage of oncological disease (ICD-10), treatment modalities, gender, weight, high/low dose, renal function and age whereever possible and meaningful [Срок оценки: 12 days, 4 weeks, 8 weeks]
Критерии участия
Критерии включения
- ≥25 years old and legally competent
- Palliative oncological therapy
- ECOG status 1, 2 or 3, incapacitated for work
- ESAS TSDS > or equals 16
- Nutritional Risk Screening > or equals 3
- Pain numerical rating scale > or equals 4
- informed consent
- for WOCBP:
- Negative pregnancy test
- Reliable contraception (Pearl Index < 1%)
Критерии исключения
- nausea > or equals grade 3 (CTCAE) or vomiting > or equals grade 2 (CTCAE) in the preceding week
- Inability to understand and complete the questionnaires
- Cannabis use in the last 6 weeks
- Alcohol addiction
- Pregnancy/lactation
- Contraindications or intolerance to the study medication (esp. psychosis)
- Simultaneous participation in other clinical studies (sumulataneous participation in non-interventional studies (i.e. biomarker-studies, registries) is allowed, if the study-aim does not interfere with measures of the second study)
- Any other condition as judged by the investigator, e.g. non-compliance
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
Германия · 4 центра
- Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH) — Hamburg
- University Hospital Schleswig-Holstein — Kiel
- University Hospital Schleswig-Holstein — Kiel
- University Hospital Schleswig-Holstein — Lübeck
Идентификаторы
NCT: NCT06097533 · BELCANTO · 2022-004137-39 · DRKS00031009