Lingzhi for Cancer Children

December 17, 2007 updated by: Chinese University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Ganoderma lucidum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Generic and cancer-specific Pediatric Quality-of-Life assessment
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Queen Elizabeth Hospital, Hong Kong
Prince of Wales Hospital, Shatin, 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

December 18, 2007

Last Update Submitted That Met QC Criteria

December 17, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CCFGrants2000.MKS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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