Status and phase
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About
A phase III double-blind randomized clinical trial on the effects of ganoderma spore lipids to the immunological response in patients with G.I. Cancers. The trial is randomized, double-blind. Cancer patients are diagnosed based on pathology or cell biology. Patients are randomized into 2 groups: both groups receive chemotherapy. Either group receives ganoderma spore lipids or placebo capsules 600mg three times a day (TID) in addition to the chemotherapy. Clinical evaluation includes chemotherapy drug toxicities, life quality improvement. Blood biochemistry tests mainly include malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis factor (TNF)-α, interleukin (IL)-1b, interleukin (IL)-6, cell flow cytometry on Th1, Th2, Th17, Treg cytokines, as well as serum cortisol, estradiol (female), progesterone (female), testosterone (male), etc.
Enrollment
Sex
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Volunteers
Inclusion criteria
Age: 18-80, male and female.
Diagnosis: imaging, cell and pathology report.
Eastern Cooperative Oncology Group (ECOG) O-2, life expectancy more than 3 months.
Chemotherapy is not contraindicated.
No apparent surgical trauma during the previous 2 weeks.
Past treatment:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups, including a placebo group
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Central trial contact
Xiaonan Cui, MD, PhD
Data sourced from clinicaltrials.gov
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