NCT02785523

Clinical Trial on Ganoderma Spore Lipids Combined With Chemo in Patients With G.I. Cancers

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xiaonan Cui · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastrointestinal Neoplasms

Interventions

Type	Name	Description
DRUG	Ganoderma Spore Lipids
DRUG	Placebo
DRUG	Chemotherapy

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-05-01
• First posted: 2016-05-30
• Last updated: 2016-05-30

Locations

1 site across 1 country: China