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Lingzhi for Cancer Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pediatric Cancers Drug: LingZhi capsule Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Study of the Clinical Effects of Ganoderma Lucidum (Ling Zhi) in Children With Cancer
Study Start Date : September 2002
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A: Lingzhi extract
Oral 300mg capsules containing Lingzhi extract (4 to 6 capsules per day as dosed by patients' age)
 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
Placebo Comparator: B: Placebo
Starch with same appearance and taste as LingZhi
 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


Outcome Measures
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Primary Outcome Measures :
  1. Generic and cancer-specific Pediatric Quality-of-Life assessment [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Cellular immune functions; blood counts and biochemistry for patient safety; infection-related morbidities; overall and event-free survival [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575926


Locations
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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, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Queen Elizabeth Hospital, Hong Kong
Princess Margaret Hospital, Hong Kong
Investigators
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Principal Investigator: Matthew MK Shing, MBBS, FRCP Department of Pediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong
More Information
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Responsible Party: Dr. Matthew Ming-kong Shing, MBBS, FRCP, Department of Pediatrics, Prince of Wales Hospital, Shatin, Hong Kong
ClinicalTrials.gov Identifier: NCT00575926    
Other Study ID Numbers: CCFGrants2000.MKS
First Posted: December 18, 2007    Key Record Dates
Last Update Posted: December 18, 2007
Last Verified: December 2007
Keywords provided by Chinese University of Hong Kong:
Randomized controlled trial
Lingzhi
Immune functions
Quality of life
Survival