Clinical Study of Ganoderma Lucidum Spore Combined With Chemotherapy
Status:
Unknown status
Trial end date:
2018-01-01
Target enrollment:
Participant gender:
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.