Carcinoma, Non-Small-Cell LungPhase 1NCT02737735
The Effect on Decreasing Chemotherapeutic Toxicity and Increasing Anti-tumor Effect of Chinese Herbs Based on Syndrome Differentiation
A Phase 1 study testing standard chemotherapy medicine combined with Chinese herbs and standard chemotherapy medicine in people with Carcinoma, Non-Small-Cell Lung, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor treatment of Chinese Herbs based on syndrome differentiation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- standard chemotherapy medicine combined with Chinese herbs and standard chemotherapy medicine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Jan 2020
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histology and cytology diagnosed IIIB or IV non-small-cell lung cancer (NSCLC) and untreated; Age > 18 ages
- Sex unlimited; ECOG (Eastern Cooperative Oncology Group) fitness score (Performance status, PS)≤2.
- White blood cell count ≥ 3 x 10E9 / L, neutrophils ≥1 x 109 p/L, hemoglobin≥80 g/L , platelet ≥100 x 10E9 / L
- ALT, AST, normal or less than 2 times, bilirubin is normal
- Serum level in the normal range;Thr ecg is normal
- Expected survival time≥ 3 months or more;
- Agreed to the treatment combined traditional Chinese medicine with western medicine
Who cannot join
- Engaged in other clinical subjects
- Pregnant or lactating women, women in childbearing age refuse contraceptives during the trail
- Severe pneumonia, tuberculosis, lung abscess, myocarditis and other malignant tumor
- Severe damage of heart, liver and kidney (cardiac function grade 3 ~ 4, ALT and/or AST 2 times more than normal , Cr more the normal limit)
- Mental illness, Refused to partner; Cannot obtain informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun-yat Sen University
Guangzhou, Guangdong, 510080
Bao-guo Sun, doctor, 13316134352, Sunbaoguo666@126.com
About this study
To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor treatment of Chinese Herbs based on syndrome differentiation
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- standard chemotherapy medicine combined with Chinese herbs, standard chemotherapy medicine
- 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.
standard chemotherapy medicine combined with Chinese herbsDrug
standard chemotherapy medicineDrug
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy combined with compound herbal medicine | Experimental | Standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks combined with compound Chinese herbal medicine for 2 years，which include 15 kinds of Chinese herbs:Thunberg fritillary bulb,antimutangenic ,cimicifuga foetida,astragalus,pinellia ,Radix Ophiopogonis ,Solanum nigrum,Hedyotis diffusa,Prunella vulgaris ,cordate houttuynia,Herba Patriniae,dried orange peel ,Codonopsis,Wolfiporia extensa,Coix seed,Rhizoma Alismatis. Receives: Drug: standard chemotherapy medicine combined with Chinese herbs |
| Chemotherapy | Active comparator | The therapy of standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks Receives: Drug: standard chemotherapy medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Measured: 36months
progression-free survival rate
Measured: 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (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.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Bao-guo, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737735
- Sponsor's protocol ID
- SBao-guo
- Status last verified
- Mar 2016
- First submitted
- 26 Mar 2016
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Decreasing Chemotherapeutic Toxicity and Increasing Anti-tumor Effect of Chinese Herbs Based on Syndrome Differentiation
- ClinicalTrials.gov ID
- NCT02737735
- Acronym / sponsor ID
- SBao-guo
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 14 Apr 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.
To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor treatment of Chinese Herbs based on syndrome differentiation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy combined with compound herbal medicine | Experimental | Drug: standard chemotherapy medicine combined with Chinese herbsStandard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks combined with compound Chinese herbal medicine for 2 years，which include 15 kinds of Chinese herbs:Thunberg fritillary bulb,antimutangenic ,cimicifuga foetida,astragalus,pinellia ,Radix Ophiopogonis ,Solanum nigrum,Hedyotis diffusa,Prunella vulgaris ,cordate houttuynia,Herba Patriniae,dried orange peel ,Codonopsis,Wolfiporia extensa,Coix seed,Rhizoma Alismatis. |
| Chemotherapy | Active comparator | Drug: standard chemotherapy medicineThe therapy of standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histology and cytology diagnosed IIIB or IV non-small-cell lung cancer (NSCLC) and untreated; Age > 18 ages
- Sex unlimited; ECOG (Eastern Cooperative Oncology Group) fitness score (Performance status, PS)≤2.
- White blood cell count ≥ 3 x 10E9 / L, neutrophils ≥1 x 109 p/L, hemoglobin≥80 g/L , platelet ≥100 x 10E9 / L
- ALT, AST, normal or less than 2 times, bilirubin is normal
- Serum level in the normal range;Thr ecg is normal
Key exclusion criteria (5 listed)
- Engaged in other clinical subjects
- Pregnant or lactating women, women in childbearing age refuse contraceptives during the trail
- Severe pneumonia, tuberculosis, lung abscess, myocarditis and other malignant tumor
- Severe damage of heart, liver and kidney (cardiac function grade 3 ~ 4, ALT and/or AST 2 times more than normal , Cr more the normal limit)
- Mental illness, Refused to partner; Cannot obtain informed consent
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 |
|---|---|---|
| standard chemotherapy medicine combined with Chinese herbs | Drug | Chemotherapy combined with compound herbal medicine |
| standard chemotherapy medicine | Drug | Chemotherapy |
Primary outcome
Overall survival rate
Time frame: 36months
progression-free survival rate
Time frame: 36months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing standard chemotherapy medicine combined with Chinese herbs and standard chemotherapy medicine in people with Carcinoma, Non-Small-Cell Lung, run by First Affiliated Hospital, Sun Yat-Sen University 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 7 inclusion and 5 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 14 Apr 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Bao-guo Sun, doctor (13316134352, Sunbaoguo666@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: 36months). The study lists 2 primary outcomes in all. 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 Apr 2016.