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Lingzhi for Cancer Children

NCT ID: NCT00575926

Last Updated: 2007-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Pediatric Cancers

Keywords

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Randomized controlled trial Lingzhi Immune functions Quality of life Survival

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A: Lingzhi extract

Oral 300mg capsules containing Lingzhi extract (4 to 6 capsules per day as dosed by patients' age)

Group Type ACTIVE_COMPARATOR

LingZhi capsule

Intervention Type DRUG

LingZhi or Placebo 300 mg x 4 or 300 mg x 6 capsules daily according to age group

B: Placebo

Starch with same appearance and taste as LingZhi

Group Type PLACEBO_COMPARATOR

LingZhi capsule

Intervention Type DRUG

LingZhi or Placebo 300 mg x 4 or 300 mg x 6 capsules daily according to age group

Interventions

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LingZhi capsule

LingZhi or Placebo 300 mg x 4 or 300 mg x 6 capsules daily according to age group

Intervention Type DRUG

Other Intervention Names

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Ganoderma lucidum

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Wales Hospital, Shatin, Hong Kong

OTHER

Sponsor Role collaborator

Queen Elizabeth Hospital, Hong Kong

OTHER

Sponsor Role collaborator

Princess Margaret Hospital, Hong Kong

OTHER_GOV

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Department of Pediatrics, Prince of Wales Hospital, Shatin, Hong Kong

Principal Investigators

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Matthew MK Shing, MBBS, FRCP

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong

Locations

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Department of Pediatrics and Adolescent Medicine, Princess Margaret Hospital

Hong Kong, , Hong Kong

Site Status

Department of Pediatrics, Queen Elizabeth Hospital

Hong Kong, , Hong Kong

Site Status

Department of Pediatrics, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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CCFGrants2000.MKS

Identifier Type: -

Identifier Source: org_study_id