Lingzhi for Cancer Children

Pediatric Cancers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575926
• Other study ID #: CCFGrants2000.MKS
• Status: Completed
• Phase: Phase 3
• First received: December 17, 2007
• Last updated: December 17, 2007
• Start date: September 2002
• Est. completion date: September 2007

Study information

• Verified date: December 2007
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pediatric Cancers

Intervention

Drug:
• LingZhi capsule
LingZhi or Placebo 300 mg x 4 or 300 mg x 6 capsules daily according to age group

Locations

Country	Name	City	State
Hong Kong	Department of Pediatrics and Adolescent Medicine, Princess Margaret Hospital	Hong Kong
Hong Kong	Department of Pediatrics, Queen Elizabeth Hospital	Hong Kong
Hong Kong	Department of Pediatrics, The Chinese University of Hong Kong	Hong Kong

Sponsors (4)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Prince of Wales Hospital, Shatin, Hong Kong, Princess Margaret Hospital, Hong Kong, Queen Elizabeth Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generic and cancer-specific Pediatric Quality-of-Life assessment		1 year	No
Secondary	Cellular immune functions; blood counts and biochemistry for patient safety; infection-related morbidities; overall and event-free survival		1 year	Yes