Clinical trial NCT00575926: Lingzhi for Cancer Children
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Study of the Clinical Effects of Ganoderma Lucidum (Ling Zhi) in Children With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pediatric Cancers
Keywords: Randomized controlled trial
Lingzhi
Immune functions
Quality of life
Survival
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Prince of Wales Hospital, Shatin, Hong Kong
name: Queen Elizabeth Hospital, Hong Kong
name: Princess Margaret Hospital, Hong Kong
First posted: 2007-12-18
Enrollment: 58
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Generic and cancer-specific Pediatric Quality-of-Life assessment
timeFrame: 1 year
Secondary outcomes:
measure: Cellular immune functions; blood counts and biochemistry for patient safety; infection-related morbidities; overall and event-free survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Pediatrics and Adolescent Medicine, Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Department of Pediatrics, Queen Elizabeth Hospital
city: Hong Kong
country: Hong Kong
facility: Department of Pediatrics, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Pediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong
name: Matthew MK Shing, MBBS, FRCP
role: PRINCIPAL_INVESTIGATOR
References: