Clinical Study of Ganoderma Lucidum Spore Combined With Chemotherapy

• Status: Unknown status
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the effect of the serum level of Superoxide Dismutase (SOD), Malondialdehyde (MDA), pro-inflammatory factors, stress hormones and Glutathione peroxidase (GSH-PX)in tumor patients with the treatment of Ganoderma lucidum spore based combination chemotherapy. Half of participants will receive Ganoderma lucidum spore and chemotherapy in combination, and the other half will receive a placebo and chemotherapy.

Study design: Phase 2. Experimental: Ganoderma lucidum spore & Chemotherapy; Placebo Comparator: Placebo & Chemotherapy.

Outcome Measure:

1. The life quality of participants was assessed with use of the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire at the initial diagnosis (baseline) and at 42 days after the treatment;

2. Investigators assessed Procedural mortality factor ligand 1(PD-L1)expression prospectively on tumour cells and tumour-infiltrating immune cells with the VENTANA PD-L1 immunohistochemistry assay;

3. National Cancer Institute Common Toxicity Criteria.

Statistical analysis: All experiment results were analyzed with Statistical Product and Service Solutions (SPSS) software (version 16.0). Data are presented as mean±standard deviation and analysed by one-way ANOVA. Semi-quantitative data were compared using the Kruskal- Wallis nonparametric analysis. The results were considered statistically significant at P<0.05.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gao Yajie
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• Have been diagnosed definitely by cytopathology examination and image methods.

• Eastern Cooperative Oncology Group (ECOG) score standard: 0-2.

• Survival time may last more than 3 months.

• Normal electrocardiogram changes.

• WBC≧4.0×10*9/L, PLT≧1.5×10*9/L, HB≧100.0g/L

• Have no cardiac disease, no myocardial infarction in past 6 months.

Exclusion Criteria:

• Receiving other effective treatments currently.

• Have diabetes or another chronic metabolic disorder (BIM <18 or >25).

• Serious pyogenic or chronic infections.

• Have hematologic disease or coagulation dysfunction.

• Unhealed serious cerebral disease or tumor, depression disorders, senile dementia or other mental diseases.

• Pregnant and lactation women, allergic constitution.

• Combined liver, kidney, blood system Primary serious diseases, mental patients.

• Within the past 4 weeks to participate in other clinical trials of patients.