Clinical Study of Ganoderma Lucidum Spore Combined With Chemotherapy

NCT02844114 | Unknown Phase 2 DMC

• 1 other identifier: NationalHealthyFood G20090069
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.National Cancer Institute Common Toxicity Criteria.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Ganoderma Lucidum Spore; Carcinoma, Non-Small-Cell Lung; Chemotherapy; Gemcitabine; Cisplatin

Outcome Measures

Primary Outcomes (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.

  42 days

Secondary Outcomes (1)

• 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.

  42 days

Other Outcomes (1)

• Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to National Cancer Institute Common Toxicity Criteria

  42 days

Study Arms (2)

Ganoderma lucidum spore & Chemotherapy

EXPERIMENTAL

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).

Drug: Ganoderma lucidum spore; Drug: Chemotherapy

Placebo & Chemotherapy

PLACEBO COMPARATOR

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).

Drug: Placebo; Drug: Chemotherapy

Interventions

Ganoderma lucidum spore DRUG

G 300mg, 5 tablets by mouth

Also known as: G

Ganoderma lucidum spore & Chemotherapy

Placebo DRUG

Sugar pill manufactured to mimic tramadol 1500mg tablet

Also known as: P

Placebo & Chemotherapy

Chemotherapy DRUG

iv.30 minutes

Also known as: Gemcitabine, Cisplatin

Ganoderma lucidum spore & Chemotherapy; Placebo & Chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gao Yajie: lead

Study Sites (1)

First Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yajie Gao, Professor

  First Hospital of Dalian Medical University

  STUDY CHAIR

Central Study Contacts

Yajie Gao, Professor

CONTACT

0411-83635963; gaoyajie100@126.com

Aiping Tan, Professor

CONTACT

0411-83635963; 1808997601@189.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 19, 2016
• First Posted: July 26, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)