Trial | NCT00575926  Report issue

Title

Lingzhi for Cancer Children
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study of the Clinical Effects of Ganoderma Lucidum (Ling Zhi) in Children With Cancer

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    58
Ganoderma lucidum (Lingzhi) is a Traditional Chinese Medicine which is widely used as a means to 'strengthen immunity' among patients with cancers. However, there is no published randomized controlled clinical trial on its efficacy and safety despite the many in vitro studies on its anti-viral, anti-oxidative, anti-tumour, radioprotective, hepato-protective and immunomodulatory effects. This study was a randomized, double-blind, placebo-controlled, parallel clinical trial that investigated the benefits and safety of Ganoderma lucidum (Lingzhi) in treating children with cancers. Patients were randomized to receive identical capsules of either Lingzhi or placebo for six months. The primary outcome was the general Paediatric Quality of Life score. Secondary outcomes included immune functions, infection-related morbidities, complete blood counts and serum biochemistry, and overall and event-free survival.
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.
Study Started
Sep 30
2002
Study Completion
Sep 30
2007
Last Update
Dec 18
2007
Estimate

Drug LingZhi capsule

LingZhi or Placebo 300 mg x 4 or 300 mg x 6 capsules daily according to age group

  • Other names: Ganoderma lucidum

A: Lingzhi extract Active Comparator

Oral 300mg capsules containing Lingzhi extract (4 to 6 capsules per day as dosed by patients' age)

B: Placebo Placebo Comparator

Starch with same appearance and taste as LingZhi

Criteria 

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
No Results Posted