Lingzhi for Cancer Children

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00575926
First received: December 17, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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 Intervention Phase
Pediatric Cancers
Drug: LingZhi capsule
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Generic and cancer-specific Pediatric Quality-of-Life assessment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Enrollment: 58
Study Start Date: September 2002
Study Completion Date: September 2007
Arms Assigned Interventions
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

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

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575926

Locations
Hong Kong
Department of Pediatrics, The Chinese University of Hong Kong
Hong Kong, Hong Kong
Department of Pediatrics, Queen Elizabeth Hospital
Hong Kong, Hong Kong
Department of Pediatrics and Adolescent Medicine, Princess Margaret Hospital
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
Principal Investigator: Matthew MK Shing, MBBS, FRCP Department of Pediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Dr. Matthew Ming-kong Shing, MBBS, FRCP, Department of Pediatrics, Prince of Wales Hospital, Shatin, Hong Kong
ClinicalTrials.gov Identifier: NCT00575926     History of Changes
Other Study ID Numbers: CCFGrants2000.MKS
Study First Received: December 17, 2007
Last Updated: December 17, 2007
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Randomized controlled trial
Lingzhi
Immune functions
Quality of life
Survival

ClinicalTrials.gov processed this record on April 17, 2014