NCT00575926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
Last Updated

December 18, 2007

Status Verified

December 1, 2007

First QC Date

December 17, 2007

Last Update Submit

December 17, 2007

Conditions

Pediatric Cancers

Keywords

Randomized controlled trialLingzhiImmune functionsQuality of lifeSurvival

Outcome Measures

Primary Outcomes (1)

  • Generic and cancer-specific Pediatric Quality-of-Life assessment

    1 year

Secondary Outcomes (1)

  • Cellular immune functions; blood counts and biochemistry for patient safety; infection-related morbidities; overall and event-free survival

    1 year

Study Arms (2)

A: Lingzhi extract

ACTIVE COMPARATOR

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

Drug: LingZhi capsule

B: Placebo

PLACEBO COMPARATOR

Starch with same appearance and taste as LingZhi

Drug: LingZhi capsule

Interventions

LingZhi capsuleDRUG

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

Also known as: Ganoderma lucidum
A: Lingzhi extractB: Placebo

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Pediatrics and Adolescent Medicine, Princess Margaret Hospital

Hong Kong, Hong Kong

Location

Department of Pediatrics, Queen Elizabeth Hospital

Hong Kong, Hong Kong

Location

Department of Pediatrics, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Study Officials

  • Matthew MK Shing, MBBS, FRCP

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 18, 2007

Study Start

September 1, 2002

Study Completion

September 1, 2007

Last Updated

December 18, 2007

Record last verified: 2007-12

Locations

HK(3)