Pediatric CancersPhase 3NCT00575926
Lingzhi for Cancer Children
A Phase 3 study testing LingZhi capsule in people with Pediatric Cancers, run by Chinese University of Hong Kong at 3 sites in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Pediatric Cancers
- What is being tested?
- LingZhi capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 3 sitesHong Kong
- Study dates
- Sep 2002to Sep 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Department of Pediatrics and Adolescent Medicine, Princess Margaret Hospital
Hong Kong
Department of Pediatrics, Queen Elizabeth Hospital
Hong Kong
Department of Pediatrics, The Chinese University of Hong Kong
Hong Kong
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Cancers
- Being tested
- LingZhi capsule
- Keywords
- Randomized controlled trial, Lingzhi, Immune functions, Quality of life, Survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LingZhi capsuleDrug
Also called Ganoderma lucidum
LingZhi or Placebo 300 mg x 4 or 300 mg x 6 capsules daily according to age group
| Study group | Role | What they receive |
|---|---|---|
| A: Lingzhi extract | Active comparator | Oral 300mg capsules containing Lingzhi extract (4 to 6 capsules per day as dosed by patients' age) Receives: Drug: LingZhi capsule |
| B: Placebo | Placebo comparator | Starch with same appearance and taste as LingZhi Receives: Drug: LingZhi capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generic and cancer-specific Pediatric Quality-of-Life assessment
Measured: 1 year
Secondary outcomes (1)
Cellular immune functions; blood counts and biochemistry for patient safety; infection-related morbidities; overall and event-free survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startSep 2002
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancersStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Queen Elizabeth Hospital, Hong Kong, Princess Margaret Hospital, Hong Kong
- Investigators
- Matthew MK Shing, MBBS, FRCP, Principal investigator, Department of Pediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575926
- Sponsor's protocol ID
- CCFGrants2000.MKS
- Status last verified
- Dec 2007
- First submitted
- 17 Dec 2007
- Last updated
- 18 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Study of the Clinical Effects of Ganoderma Lucidum (Ling Zhi) in Children With Cancer
- ClinicalTrials.gov ID
- NCT00575926
- Acronym / sponsor ID
- CCFGrants2000.MKS
- Conditions
- Pediatric Cancers
- Keywords
- Randomized controlled trial, Lingzhi, Immune functions, Quality of life, Survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Queen Elizabeth Hospital, Hong Kong, Princess Margaret Hospital, Hong Kong
- Study start
- Sep 2002
- Study completion
- Sep 2007 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Lingzhi extract | Active comparator | Drug: LingZhi capsuleOral 300mg capsules containing Lingzhi extract (4 to 6 capsules per day as dosed by patients' age) |
| B: Placebo | Placebo comparator | Drug: LingZhi capsuleStarch with same appearance and taste as LingZhi |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LingZhi capsuleAlso: Ganoderma lucidumLingZhi or Placebo 300 mg x 4 or 300 mg x 6 capsules daily according to age group | Drug | A: Lingzhi extract, B: Placebo |
Primary outcome
Generic and cancer-specific Pediatric Quality-of-Life assessment
Time frame: 1 year
1 secondary outcome
Cellular immune functions; blood counts and biochemistry for patient safety; infection-related morbidities; overall and event-free survival
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew MK Shing, MBBS, FRCP principal investigator
Department of Pediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LingZhi capsule in people with Pediatric Cancers, run by Chinese University of Hong Kong at 3 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generic and cancer-specific Pediatric Quality-of-Life assessment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2007.