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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Xiaonan Cui

Criteria

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:

• Biological treatment: at least 4 weeks after previous treatment with immunotherapy or other biological; chemotherapy, at least 6 months after last treatment with chemotherapy and or target therapy.

• Surgery: had not received transplantation surgery, at least 2 weeks after last major surgery.

Exclusion Criteria:

• A purulent and chronic infection of wound healing delayed.

• Diseases of the blood system.

• Abnormal blood coagulation function.

• Severe brain disease or primary brain tumors without control, and mentally ill person.

• Patients with brain metastases.

• Pregnant or lactating women.

• Patients (male/female) with fertility, But the patients themselves or their spouses do not take effective contraception.

• Allergic constitution.

• In addition, patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.