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

Study Overview
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Brief Summary
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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
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Gastrointestinal Neoplasms

Intervention / Treatment
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* Drug: Ganoderma Spore Lipids
* Drug: Placebo
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G. SPORE LIPIDS<br>Form: Capsule Dosage and frequency: This group receives ganoderma spore lipids capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles. | Drug: Ganoderma Spore Lipids<br> <br> * Other names: G. SPORE LIPIDS;Drug: Chemotherapy<br> <br> |
| Placebo Comparator: Placebo<br>Form: Capsule Dosage and frequency: This group receives placebo capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles. | Drug: Placebo<br> <br> Drug: Chemotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events: neutropenia, leukopenia, thrombocytopenia, anemia, nausea, vomit, fatigue, loss of appetite. |  | Cycle 2, cycle 4, cycle 6(each cycle is 21 days). | 
| Assessing the quality of life(QOL) in 5 grades and recording: appetite, mental state, sleep, fatigue, pain, attitude towards treatment, daily life ability, treatment of severity of side effects. |  | Cycle 2, cycle 4, cycle 6(each cycle is 21 days). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Th1/Th2, Th17/Treg in blood. |  | Cycle 2, cycle 4, cycle 6(each cycle is 21 days). | 
| Interleukin(IL)-1b, interleukin(IL)-6, tumor necrosis factor(TNF)-α in blood. |  | Cycle 2, cycle 4, cycle 6(each cycle is 21 days). | 
| Estradiol (female), progesterone (female), testosterone (male) in blood. |  | Cycle 2, cycle 4, cycle 6(each cycle is 21 days). | 
| Vanillylmandelic acid (VMA) in urine. |  | Cycle 2, cycle 4, cycle 6(each cycle is 21 days). |