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Completed

NCT Number: NCT00575926

Lingzhi for Cancer Children

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.

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Key information

Conditions

Pediatric Cancers

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Pediatrics and Adolescent Medicine, Princess Margaret Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LingZhi capsule

Drug

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

Other names: Ganoderma lucidum

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Cellular immune functions; blood counts and biochemistry for patient safety; infection-related morbidities; overall and event-free survival

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Prince of Wales Hospital, Shatin, Hong Kong
  • Princess Margaret Hospital, Hong Kong
  • Queen Elizabeth Hospital, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2007
First posted
Dec 18, 2007
Registry last updated
Dec 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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