Lingzhi for Cancer Children
关键词
抽象
描述
Alternative and complementary medicine are widely used in treating children with cancers. A population-based survey in British Columbia revealed that they were used by 42% of the respondents. Among Chinese in Hong Kong, Traditional Chinese Medicine (TCM) is also widely practiced. Some 60% of the population had consulted TCM practitioners at one time or another. TCM use could be dated back to more than five thousand years ago, and written records were available for over two thousand years. TCM is considered to be an integral part of the Chinese culture. In our experience, TCM is believed to be commonly used to 'strengthen immunity and promote health' among local children with cancers, despite the lack of well-designed study to prove its usefulness. Ganoderma lucidum (Ling Zhi) is a mushroom long-used in China for a broad range of disorders. Its use is common in the general population and among both adults and children with a wide range of malignancies. However, there is no randomized controlled trial to support its clinical efficacy and safety. Therefore, we conducted this clinical trial of Ganoderma lucidum (Ling Zhi) among Hong Kong children with cancers.
日期
| 最后验证: | 11/30/2007 |
| 首次提交: | 12/16/2007 |
| 提交的预估入学人数: | 12/16/2007 |
| 首次发布: | 12/17/2007 |
| 上次提交的更新: | 12/16/2007 |
| 最近更新发布: | 12/17/2007 |
| 实际学习开始日期: | 08/31/2002 |
| 预计完成日期: | 08/31/2007 |
状况或疾病
干预/治疗
Drug: LingZhi capsule
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: A: Lingzhi extract Oral 300mg capsules containing Lingzhi extract (4 to 6 capsules per day as dosed by patients' age) | |
| Placebo Comparator: B: Placebo Starch with same appearance and taste as LingZhi |
资格标准
| 有资格学习的年龄 | 2 Years 至 2 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Male and female patients aged 2-18 years - Acute lymphoblastic leukaemia who completed induction chemotherapy and pending maintenance chemotherapy treatment - Solid tumours completed chemotherapy - Aute myeloid leukaemia who completed induction and consolidation chemotherapy treatment - All patients and their parents signed informed written consent Exclusion Criteria: - Relapsed cancer patients - Received Traditional Chinese Medicine (TCM) treatment within preceding one month - Could not swallow capsules - Syndromal disorders (e.g. Down syndrome) - History of hypersensitivity reaction to Lingzhi or any TCM - Significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, cardiovascular or allergic diseases - In the judgement of investigators were unable to comply with study protocol requirements |
结果
主要结果指标
1. Generic and cancer-specific Pediatric Quality-of-Life assessment [1 year]
次要成果指标
1. Cellular immune functions; blood counts and biochemistry for patient safety; infection-related morbidities; overall and event-free survival [1 year]
