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Clinical Study of Ganoderma Lucidum Spore Combined With Chemotherapy

NCT02844114 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-03-31

No results posted yet for this study

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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Ganoderma lucidum spore

G 300mg, 5 tablets by mouth

DRUG

Placebo

Sugar pill manufactured to mimic tramadol 1500mg tablet

DRUG

Chemotherapy

iv.30 minutes

Sponsors & Collaborators

  • Gao Yajie

    lead OTHER

Principal Investigators

  • Yajie Gao, Professor · First Hospital of Dalian Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02844114 on ClinicalTrials.gov