Yunzhi Essence to Improve the Quality of Life of Patients With Advanced Stage of Cancer: A Randomized, Double-blinded, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Score change of McGilll QOL-Hong Kong
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Placebo
Subjects will take 2 placebo capsules, 4 times daily, for 6 months
干预措施: Placebo (Other)
Active treatment (Yunzhi Essence)
Subjects will take 2 Yunzhi capsules, 4 times daily, for 6 months.
干预措施: Yunzhi Essence (Drug)
结局指标
主要结局
Score change of McGilll QOL-Hong Kong
时间窗: 6 months
McGill QOL-Hong Kong questionnaire will be used to measure the quality of life of subjects. It consists of 16 items and also a single item rating the overall QOL. All the response categories are based on a numerical scale from 0 to 10, with verbal anchors at the ends of the scale. The higher the score, the better the quality of life.
次要结局
- Use of rescue pain medication(From baseline to 6 months)
- Changes in tumor marker level(6 months)
- Number of interventional medical treatments(From baseline to 6 months)
- Level change of Alanine Transaminase (ALT)(From baseline to 6 months)
- Survival rate(From baseline to 6 months)
- Changes in immunological levels(6 months)
- Score change of Edmonton Symptom Assessment System (ESAS)(6 months)
- Level change of Uric acid(From baseline to 6 months)
- Level change of Blood urea nitrogen (BUN)(From baseline to 6 months)
- Level change of Alkaline Phosphatase (ALP)(From baseline to 6 months)
- Level change of Gamma-glutamyl Transferase (GGT)(From baseline to 6 months)
- Level change of blood markers(From baseline to 6 months)
- Level change of total bilirubin(From baseline to 6 months)
- Level change of Aspartate Transferase (AST)(From baseline to 6 months)
- Level change of Creatinine(From baseline to 6 months)
- Level change of Sodium(From baseline to 6 months)
- Level change of Potassium(From baseline to 6 months)
- Change of urine analysis(6 months)
- Change in Chinese medicine symptom score(6 months)
- Change in body weight(From baseline to 6 months)
- Number of oral ulcer(From baseline to 6 months)
- Changes in immunological levels(4 months)
- Changes in tumor marker level(4 months)
- Change of urine analysis(2 months)
- Change of urine analysis(4 months)
- Change in Chinese medicine symptom score(2 months)
- Change in Chinese medicine symptom score(4 months)
研究者
Prof. Lin Zhixiu
Professor
Chinese University of Hong Kong