Carcinoma, Non-Small-Cell LungPhase 2LCKY2015-21(x)NCT02844114
Clinical Study of Ganoderma Lucidum Spore Combined With Chemotherapy
A Phase 2 study testing Ganoderma lucidum spore and Chemotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Gao Yajie at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Ganoderma lucidum spore and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Hospital of Dalian Medical University
Dalian, Liaoning, 116000
Yajie Gao, Professor, 0411-83634153, gaoyajie@126.com
Yan Dong, Physician, 0411-83634153, dongyan979828@hotmail.com
About this study
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.
Read more
Outcome Measure:
- 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;
- 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;
- 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.
Read the 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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Ganoderma lucidum spore, Placebo, Chemotherapy
- Keywords
- Ganoderma Lucidum Spore, Carcinoma, Non-Small-Cell Lung, Chemotherapy, Gemcitabine, Cisplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganoderma lucidum sporeDrug
Also called G
G 300mg, 5 tablets by mouth
PlaceboDrug
Also called P
Sugar pill manufactured to mimic tramadol 1500mg tablet
ChemotherapyDrug
Also called Gemcitabine, Cisplatin
iv.30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Placebo; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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)
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gao Yajie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gao Yajie, The First Affiliated Hospital of Dalian Medical University
- Investigators
- Yajie Gao, Professor, Study chair, First Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844114
- Sponsor's protocol ID
- NationalHealthyFood G20090069
- Acronym
- LCKY2015-21(x)
- Status last verified
- Mar 2017
- First submitted
- 19 Jun 2016
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures within 6 months of study completion.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Ganoderma Lucidum Spore Combined With Chemotherapy
- ClinicalTrials.gov ID
- NCT02844114
- Acronym / sponsor ID
- LCKY2015-21(x) / NationalHealthyFood G20090069
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Ganoderma Lucidum Spore, Carcinoma, Non-Small-Cell Lung, Chemotherapy, Gemcitabine, Cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gao YajieUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 26 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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;
- 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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ganoderma lucidum spore & Chemotherapy | Experimental | Drug: Ganoderma lucidum spore, Drug: ChemotherapyGanoderma 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). |
| Placebo & Chemotherapy | Placebo comparator | Drug: Placebo, Drug: ChemotherapyPlacebo 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ganoderma lucidum sporeAlso: GG 300mg, 5 tablets by mouth | Drug | Ganoderma lucidum spore & Chemotherapy |
| PlaceboAlso: PSugar pill manufactured to mimic tramadol 1500mg tablet | Drug | Placebo & Chemotherapy |
| ChemotherapyAlso: Gemcitabine, Cisplatiniv.30 minutes | Drug | Ganoderma lucidum spore & Chemotherapy, Placebo & Chemotherapy |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures within 6 months of study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yajie Gao, Professor study chair
First Hospital of Dalian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ganoderma lucidum spore and Chemotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Gao Yajie at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yajie Gao, Professor (0411-83635963, gaoyajie100@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.