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

Phase 3
2 Years
18 Years
Not Enrolling
Pediatric Cancers

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Generic and cancer-specific Pediatric Quality-of-Life assessment

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Matthew MK Shing, MBBS, FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Pediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong


Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:




Start Date:

September 2002

Completion Date:

September 2007

Related Keywords:

  • Pediatric Cancers
  • Randomized controlled trial
  • Lingzhi
  • Immune functions
  • Quality of life
  • Survival