Clinical trial · Interventional
Lingzhi for Cancer Children
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study of the Clinical Effects of Ganoderma Lucidum (Ling Zhi) in Children With Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancers | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LingZhi capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A: Lingzhi extract
- description
- Oral 300mg capsules containing Lingzhi extract (4 to 6 capsules per day as dosed by patients' age)
- interventionNames
- Drug: LingZhi capsule
- type
- PLACEBO_COMPARATOR
- label
- B: Placebo
- description
- Starch with same appearance and taste as LingZhi
- interventionNames
- Drug: LingZhi capsule
Primary outcomes (1)
- measure
- Generic and cancer-specific Pediatric Quality-of-Life assessment
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available