Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of 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: Yunzhi Essence, Placebo.
- Кому может быть актуально
- Состояния в реестре: Cancer, Palliative Care. Базовые параметры: 21 лет — 89 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
- Гонконг
- 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
Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of Cancer: A Randomized, Double-blinded, Placebo-controlled Trial
Обзор
A randomized, double-blinded, placebo-controlled clinical trial using a Chinese Medicine 'Coriolus Versicolor for improving the quality of life of patients with advanced-stage cancer. Subjects will be randomized into a treatment group or placebo group for 6 months.
Подробное описание
According to the Compendium of Materia Medica, a classic encyclopedia for Chinese medicines written by the venerated Physician Li ShiZhen of the Ming dynasty, Yunzhi (Coriolus Versicolor) is treasured as a superbly valuable herb as it not only can strengthen and consolidate the body's resistance, as well as reinforce and nourish a person's marrow and kidney essence and also is harmless to patients. Recent research found that the extract from Yunzhi, named as polysaccharide-peptide (PSP), could inhibit the growth of human hematoma cell line \& sarcoma and was proved to have direct anti-cancer effects.
Quality of life (QOL) of patients is the ultimate goal of palliative care as endorsed by the World Health Organization (WHO) in 1990. When survival is limited in advanced incurable diseases, quality of life is most important. Patients with advanced cancer (palliative) often manifest numerous physical and psychological symptoms and a poor quality of life. While maintenance of the quality of life of advanced cancer patients is important, the physical dimension of quality of life still needs improvement, especially in the palliative stage. To date, there is no specific supportive Traditional Chinese Medicine(TCM)-related products that have been proven in randomized controlled trials for alleviating these debilitating symptoms and improving their quality of life. The present study aims to scientifically evaluate whether a Yunzhi product named G.E. Yunzhi-Essence is effective and safe in improving the QOL of palliative patients with advanced cancer.
Вмешательства
- Препарат Yunzhi Essence
Yunzhi Essence capsule - Другое Placebo
Placebo capsules
Первичные конечные точки
- Score change of McGilll QOL-Hong Kong [Срок оценки: 6 months]
Вторичные конечные точки (12)
- Survival rate [Срок оценки: From baseline to 6 months]
- Changes in immunological levels [Срок оценки: 4 months]
- Changes in immunological levels [Срок оценки: 6 months]
- Changes in tumor marker level [Срок оценки: 4 months]
- Changes in tumor marker level [Срок оценки: 6 months]
- Score change of Edmonton Symptom Assessment System (ESAS) [Срок оценки: 6 months]
- Use of rescue pain medication [Срок оценки: From baseline to 6 months]
- Number of interventional medical treatments [Срок оценки: From baseline to 6 months]
- Level change of total bilirubin [Срок оценки: From baseline to 6 months]
- Level change of Alkaline Phosphatase (ALP) [Срок оценки: From baseline to 6 months]
- Level change of Alanine Transaminase (ALT) [Срок оценки: From baseline to 6 months]
- Level change of Aspartate Transferase (AST) [Срок оценки: From baseline to 6 months]
Критерии участия
Критерии включения
- Diagnosed with advanced cancer according to the definition from American Cancer Society;
- According to the experience of the doctor, by using Palliative Prognostic Index (score>4), integrated with past cases and professional knowledge judged to have life expectancy not less than six months to two years;
- Abbreviated mental test (AMT) score of 6 or above;
- Voluntarily participate in this clinical trial and sign the informed consent form (acceptance of close relatives signed informed consent on behalf of the patient);
- Refer to the national standard for Clinic terminology of traditional Chinese medical diagnosis and treatment-Part 2:Syndromes/patterns, syndrome of "damp heat spleen" and "spleen deficiency with water stop" (Fulfill 2 of the main symptoms and 2 of the secondary symptoms).
Критерии исключения
- Patients with a history of allergy to traditional Chinese medicine or Yunzhi;
- Patients who required nasal feeding or difficulty swallowing;
- Patients with comatose/semi-conscious, cognitively impaired with dementia/confusion, physically too ill with extremely poor general condition, or there was a language barrier.
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
- Тройное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Гонконг · 1 центр
- School of Chinese Medicine — Гонконг
Идентификаторы
NCT: NCT05754801 · Yunzhi study