Clinical trial · Interventional
Clinical Study of Ganoderma Lucidum Spore Combined With Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Ganoderma lucidum spore | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ganoderma lucidum spore & Chemotherapy
- description
- Ganoderma lucidum spore 1500mg tablet by mouth, every 8 hours for 7 days; Gemcitabine 1000mg intravenously on days 1 and 8 every 3 weeks(iv.over 30 minutes) or cisplatin 75mg intravenously on days 2 and 3 every 3 weeks (iv.15-30 minutes).
- interventionNames
- Drug: Ganoderma lucidum spore
- Drug: Chemotherapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo & Chemotherapy
- description
- Placebo tablet by mouth, every 8 hours for 7 days; Gemcitabine 1000mg intravenously on days 1 and 8 every 3 weeks(iv.over 30 minutes) or cisplatin 75mg intravenously on days 2 and 3 every 3 weeks (iv.15-30 minutes).
- interventionNames
- Drug: Placebo
- Drug: Chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
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