Lingzhi for Cancer Children

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Collaborators: Prince of Wales Hospital, Shatin, Hong Kong; Princess Margaret Hospital, Hong Kong; Queen Elizabeth Hospital, Hong Kong

Criteria

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