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Lingzhi for Cancer Children

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ClinicalTrials.gov Identifier: NCT00575926
Recruitment Status : Completed
First Posted : December 18, 2007
Last Update Posted : December 18, 2007
Sponsor:
Collaborators:
Prince of Wales Hospital, Shatin, Hong Kong
Queen Elizabeth Hospital, Hong Kong
Princess Margaret Hospital, Hong Kong
Information provided by:
Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE December 17, 2007
First Posted Date  ICMJE December 18, 2007
Last Update Posted Date December 18, 2007
Study Start Date  ICMJE September 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2007)
Generic and cancer-specific Pediatric Quality-of-Life assessment [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2007)
Cellular immune functions; blood counts and biochemistry for patient safety; infection-related morbidities; overall and event-free survival [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lingzhi for Cancer Children
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Parallel Study of the Clinical Effects of Ganoderma Lucidum (Ling Zhi) in Children With Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pediatric Cancers
Intervention  ICMJE Drug: LingZhi capsule
LingZhi or Placebo 300 mg x 4 or 300 mg x 6 capsules daily according to age group
Other Name: Ganoderma lucidum
Study Arms  ICMJE
  • Active Comparator: A: Lingzhi extract
    Oral 300mg capsules containing Lingzhi extract (4 to 6 capsules per day as dosed by patients' age)
    Intervention: Drug: LingZhi capsule
  • Placebo Comparator: B: Placebo
    Starch with same appearance and taste as LingZhi
    Intervention: Drug: LingZhi capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2007)
58
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00575926
Other Study ID Numbers  ICMJE CCFGrants2000.MKS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Matthew Ming-kong Shing, MBBS, FRCP, Department of Pediatrics, Prince of Wales Hospital, Shatin, Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE
  • Prince of Wales Hospital, Shatin, Hong Kong
  • Queen Elizabeth Hospital, Hong Kong
  • Princess Margaret Hospital, Hong Kong
Investigators  ICMJE
Principal Investigator: Matthew MK Shing, MBBS, FRCP Department of Pediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP