Clinical Study of Ganoderma Lucidum Spore Combined With Chemotherapy

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.

Timeline

Start

2016-01

Primary completion

2018-01

Completion

2018-01

Drugs

Indications