Clinical Study of Ganoderma Lucidum Spore Combined With Chemotherapy
NCT ID: NCT02844114
Last Updated: 2017-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2016-01-31
2018-01-31
Brief Summary
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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.
Detailed Description
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Ganoderma lucidum spore can reduce bone narrow depression, gastrointestinal mucosal damage and enhance the immunity. Previous studies have reported that Ganoderma lucidum spore have antivirus, antineoplastic, decreasing blood lipids, hypoglycemic and anti-hypoxic activities. The objective of this study is to observe the effect of Ganoderma lucidum spore based combination chemotherapy in treatment of patients. And then to detect the serum level of SOD, MDA, pro-inflammatory factors, stress hormones and GSH-PX.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ganoderma lucidum spore & Chemotherapy
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).
Ganoderma lucidum spore
G 300mg, 5 tablets by mouth
Chemotherapy
iv.30 minutes
Placebo & Chemotherapy
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).
Placebo
Sugar pill manufactured to mimic tramadol 1500mg tablet
Chemotherapy
iv.30 minutes
Interventions
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Ganoderma lucidum spore
G 300mg, 5 tablets by mouth
Placebo
Sugar pill manufactured to mimic tramadol 1500mg tablet
Chemotherapy
iv.30 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
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Gao Yajie
OTHER
Responsible Party
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Gao Yajie
Clinical Professor
Principal Investigators
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Yajie Gao, Professor
Role: STUDY_CHAIR
First Hospital of Dalian Medical University
Locations
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First Hospital of Dalian Medical University
Dalian, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Yajie Gao, Professor
Role: primary
Yan Dong, Physician
Role: backup
Other Identifiers
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NationalHealthyFood G20090069
Identifier Type: -
Identifier Source: org_study_id