Lung NeoplasmsNCT02603016
Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma
A study testing GLSE compound, Maitake mushroom extract compound and Ginseng compound in people with Lung Neoplasms and Breast Neoplasms, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This study evaluates the efficacy of clinical nutrition to treat lung neoplasms and breast carcinoma.We estimate there will be 480 patients accepted.120 patients will receive GLSE compound,120 patients will recrive Maitake mushroom extract compound,120 patients will recrive Rinseng compound,and 120 patients will be as… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Neoplasms, Breast Neoplasms
- What is being tested?
- GLSE compound, Maitake mushroom extract compound and Ginseng compound
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Feb 2017
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lung cancer and breast cancer patients confirmed by surgery pathology;
- ECOG physical stamina score of 0~3 points;
- Expected lifetime > 3 months;
- Need to receive radiation and chemotherapy;
- Heart, liver and kidney function and blood picture is normal,WBC≥4×109/L, neutrophil count≥ 2 x 109 / L,platelet count≥100×109/L, hemoglobin≥100 g/L;
- To follow-up, good adherence
Who cannot join
- Allergic to text drug;
- Pregnancy or lactation women;
- Suffering from mental illness of not easy to control,
- Have serious mental or cognitive dysfunction;
- Can not comply with the experimental scheme or can't cooperate with the follow-up;
- The patients who are unfavorable to the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Clinical Nutrition That Research Safty and Efficacy in Lung Neoplasms And Breast Carcinoma
This study evaluates the efficacy of clinical nutrition to treat lung neoplasms and breast carcinoma.We estimate there will be 480 patients accepted.120 patients will receive GLSE compound,120 patients will recrive Maitake mushroom extract compound,120 patients will recrive Rinseng compound,and 120 patients will be as blank countrol group.Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma
Read the detailed description
GLSE compound、Maitake mushroom extract compound and Rinseng compound have different mechanism on enhancing immunity.This clinicaltrial compare them the immune effect in the progress of treating lung neoplasms and breast carcinoma.Within the 42 days,we will abide by the plan to evaluate the immunity enhancement by monitoring mmune effector molecules.
- Conditions
- Lung Neoplasms, Breast Neoplasms
- Being tested
- GLSE compound, Maitake mushroom extract compound, Ginseng compound
- Keywords
- Clinical Nutrition
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLSE compoundDrug
Maitake mushroom extract compoundDrug
Ginseng compoundDrug
| Study group | Role | What they receive |
|---|---|---|
| GLSE compound group | Experimental | GLSE compound 2g each time by mouth,twice a day for 42 days. Receives: Drug: GLSE compound |
| Maitake mushroom extract compound group | Experimental | Maitake mushroom extract compound 2 tables each time by mouth,twice a day for 42 days. Receives: Drug: Maitake mushroom extract compound |
| Ginseng compound group | Experimental | Ginseng compound 2 tables each time by mouth,twice a day for 42 days. Receives: Drug: Ginseng compound |
| blank control group | No intervention | Take nothing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-lymphocyte cell subsets
T-lymphocyte cell subsets contains CD3+、CD4+、CD8+、CD28-、CD28+、CD4+CD25+、HLADR+、HLADR-,measured these cells concentration level
Measured: three mouths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyong Wu, Chinese PLA General Hospital
- Investigators
- Shunchang Jiao, Doctor, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603016
- Sponsor's protocol ID
- PLAGHS201503601
- Status last verified
- Mar 2017
- First submitted
- 10 Nov 2015
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Clinical Nutrition That Research Safty and Efficacy in Lung Neoplasms And Breast Carcinoma
- ClinicalTrials.gov ID
- NCT02603016
- Acronym / sponsor ID
- PLAGHS201503601
- Conditions
- Lung Neoplasms, Breast Neoplasms
- Keywords
- Clinical Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 11 Nov 2015 (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 efficacy of clinical nutrition to treat lung neoplasms and breast carcinoma.We estimate there will be 480 patients accepted.120 patients will receive GLSE compound,120 patients will recrive Maitake mushroom extract compound,120 patients will recrive Rinseng compound,and 120 patients will be as blank countrol group.Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma
Detailed description
GLSE compound、Maitake mushroom extract compound and Rinseng compound have different mechanism on enhancing immunity.This clinicaltrial compare them the immune effect in the progress of treating lung neoplasms and breast carcinoma.Within the 42 days,we will abide by the plan to evaluate the immunity enhancement by monitoring mmune effector molecules.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GLSE compound group | Experimental | Drug: GLSE compoundGLSE compound 2g each time by mouth,twice a day for 42 days. |
| Maitake mushroom extract compound group | Experimental | Drug: Maitake mushroom extract compoundMaitake mushroom extract compound 2 tables each time by mouth,twice a day for 42 days. |
| Ginseng compound group | Experimental | Drug: Ginseng compoundGinseng compound 2 tables each time by mouth,twice a day for 42 days. |
| blank control group | No intervention | –Take nothing. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- lung cancer and breast cancer patients confirmed by surgery pathology;
- ECOG physical stamina score of 0~3 points;
- Expected lifetime > 3 months;
- Need to receive radiation and chemotherapy;
- Heart, liver and kidney function and blood picture is normal,WBC≥4×109/L, neutrophil count≥ 2 x 109 / L,platelet count≥100×109/L, hemoglobin≥100 g/L;
Key exclusion criteria (6 listed)
- Allergic to text drug;
- Pregnancy or lactation women;
- Suffering from mental illness of not easy to control,
- Have serious mental or cognitive dysfunction;
- Can not comply with the experimental scheme or can't cooperate with the follow-up;
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 |
|---|---|---|
| GLSE compound | Drug | GLSE compound group |
| Maitake mushroom extract compound | Drug | Maitake mushroom extract compound group |
| Ginseng compound | Drug | Ginseng compound group |
Primary outcome
T-lymphocyte cell subsets
Time frame: three mouths
T-lymphocyte cell subsets contains CD3+、CD4+、CD8+、CD28-、CD28+、CD4+CD25+、HLADR+、HLADR-,measured these cells concentration level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
Related trials for Lung Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Shunchang Jiao, Doctor study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLSE compound, Maitake mushroom extract compound and Ginseng compound in people with Lung Neoplasms and Breast Neoplasms, run by Chinese PLA General Hospital 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 6 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: finished, as of the sponsor's last update on 14 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-lymphocyte cell subsets (time frame: three mouths). 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 14 Mar 2017.