Clinical Study of Ganoderma Lucidum Spore Combined With Chemotherapy (LCKY2015-21(x))

March 30, 2017 updated by: Gao Yajie

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Ganoderma lucidum spore, as a natural substance is widely recognized and used in tumor patients for its nutritive value. The effect has proved that Ganoderma lucidum spore which has polysaccharide, triterpene compounds and the other trace elements, combined with chemotherapy can reduce toxicity and enhance efficacy in patients.

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • Recruiting
        • First Hospital of Dalian Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yajie Gao, Professor
        • Sub-Investigator:
          • Yan Dong, Physician
        • Sub-Investigator:
          • Bin Zhang, Physician
        • Sub-Investigator:
          • Hui Mi, Postgraduate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Ganoderma lucidum spore
G 300mg, 5 tablets by mouth
Other Names:
  • G
Drug: Chemotherapy
iv.30 minutes
Other Names:
  • Gemcitabine, Cisplatin
Placebo Comparator: 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).
Drug: Chemotherapy
iv.30 minutes
Other Names:
  • Gemcitabine, Cisplatin
Drug: Placebo
Sugar pill manufactured to mimic tramadol 1500mg tablet
Other Names:
  • P

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 42 days
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 42 days
Investigators scored tumour cells expressing PD-L1 as a percentage of total tumour cells and tumour-infiltrating immune cells expressing PD-L1 as a percentage of tumour area, as previously described (tumour cells scored as percentage of PD-L1-expressing tumour cells)
42 days

Other Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 42 days
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gao Yajie

Investigators

  • Study Chair: Yajie Gao, Professor, First Hospital of Dalian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

June 19, 2016

First Submitted That Met QC Criteria

July 21, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NationalHealthyFood G20090069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures within 6 months of study completion.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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