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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Generic and cancer-specific Pediatric Quality-of-Life assessment
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Queen Elizabeth Hospital, Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Princess Margaret Hospital, Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2002

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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