Lung AdenocarcinomaNCT04482829
TCM in the Treatment of Lung Adenocarcinoma
A study testing Jing-yan-kang Granule and PC chemotherapy and symptomatic treatment in people with Lung Adenocarcinoma, run by Henan University of Traditional Chinese Medicine.
Trial summary
This study is to evaluate the efficacy and safety of Jin-yuan-kang granule in the treatment of lung adenocarcinoma (LUAD) preliminarily, and provide reference for further study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Adenocarcinoma
- What is being tested?
- Jing-yan-kang Granule and PC chemotherapy and symptomatic treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2020to 30 Jun 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A confirmed diagnosis of LADC.
- Age ranges from17years to75years.
- A KPS score ≥40.
- Without radiotherapy, immunotherapy and targeted therapy.
- Without participanting in any other trial.
- With signed informed consent.
Who cannot join
- Pregnant, nursing or may become pregnant women.
- The patient has a history of allergy to any of the components of the intervention drug;
- Patients with severe liver and kidney dysfunction, cardiovascular and cerebrovascular diseases.
- Unconscious or unable to communicate normally.
- Patients with poor compliance.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Jing-yuan-kang Granule in the Treatment of Lung Adenocarcinoma
This study is to evaluate the efficacy and safety of Jin-yuan-kang granule in the treatment of lung adenocarcinoma (LUAD) preliminarily, and provide reference for further study.
Read the detailed description
Lung adenocarcinoma (LUAD) is a type of non-small cell lung cancer (NSCLC) with a rapid disease progression and poor treatment effect. The LUAD patients have a short median survival time with 8-11 months. Up to now, chemotherapy is still the first-line treatment for LUAD. PC protocol (pemetrexed + cisplatin) is most commonly used, which is also recommended by NCCN guidelines. However, critical side effects have limited the application and efficacy. Patients will undergo poor quality of life, and the disease will progress rapidly. We still face the stern situation for the treatment of LUAD. It is urgent to develop new treatment and management strategies. Our previous study showed that jing-yuan-kang granule has certain curative effect on LUAD.
This is a multi-certers, randomized, controlled clinical trial to assess the efficacy and safety of Jing-yuan-kang granule in improving quality of life for LUAD patients. After a 2-week wash-out period, a total of 144 LUAD patients will be randomly assigned into experimental or control group with a ratio of 1:1. On the basis of that all the participants will receive PC chemotherapy and symptomatic treatment, the patients in the experimental group will receive jing-yuan-kang granule with no other treatments for control group. The primary outcome is quality of life. The secondary outcomes include Karnofsky (KPS) scores, clinical symptoms, and change of tumor volume. Safety and adverse events will also be assessed.
- Conditions
- Lung Adenocarcinoma
- Being tested
- Jing-yan-kang Granule, PC chemotherapy and symptomatic treatment
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jing-yan-kang GranuleDrug
Jing-yuan-kang granule will be administered 6 days on and 1 days off for 12weeks.
PC chemotherapy and symptomatic treatmentDrug
Drugs used in PC chemotherapy includes Pemetrexed and Cisplatin. Pemetrexed disodium for injection 500 mg per square meter, intravenous drip on day 1 in each treatment cycle.
Cisplatin injection 75 mg per square meter, intravenous drip from day 1 to day 3 in each treatment cycle. One treatment cycle will be continued for 21 days and 4 cycles will be performed.
If necessary, symptomatic treatment will also be used.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | On the basis of PC chemotherapy and symptomatic treatment, the patients in the experimental group will receive jing-yuan-kang granule with one dose daily. Receives: Drug: Jing-yan-kang Granule; Drug: PC chemotherapy and symptomatic treatment |
| Control Group | Other | All the patients in control group will receive PC chemotherapy and symptomatic treatment without other treatment. Receives: Drug: PC chemotherapy and symptomatic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of life will be evaluated by The European Organization for Research and Treatment of Cancer Quality of life Questinnaire Core-30(EORTC QLQ-C30) scale
A score of 1-4 will be administrated for each item in EORTC QLQ-C30 . The higher scores will indicate the worse outcomes.
Measured: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
Quality of life will be evaluated by Quality of life Questinnaire Lung Cancer-13(QLQ-LC13)
A score of 1-4 will be administrated for each item in QLQ-LC13. The higher scores will indicate the worse outcomes.
Measured: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
Secondary outcomes (4)
Karnofsky(KPS) scores
Physical conditions will be evaluated by KPS scores with a score of 0-100. A higher score will indicate a better physical conditon.
Measured: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
TCM syndrome index
TCM symptom index will be recorded and calculated referring to the Guiding Principles of Clinical Research of New Chinese Medicine Treating Primary Bronchial Lung Cancer (2002 Edition) published by National Medical Products Administration of China. A total of scores of all the related symptoms will be calculated with a 0-4 for each symptom at baseline and after treatment. A higher value will indicate a worse symptom. The difference of TCM symptoms between baseline and posttreatment will be calculated first. Then, we will obtain the TCM syndrome index by the ratio between the above difference and the scores at baseline.
Measured: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
Change of tumor volume
Change of tumor volume will be assessed by the length of longest diameter. The longger diameter will indicate worse disease.
Measured: Change at 12 weeks after treatment compared to baseline.
Adverse events will be evaluated and recorded at any time.
Safety
Measured: at baseline, up to 6 weeks and 12 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start15 Sep 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482829
- Sponsor's protocol ID
- TCM for lung adenocarcinoma
- Status last verified
- Jul 2020
- First submitted
- 3 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Jing-yuan-kang Granule in the Treatment of Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04482829
- Acronym / sponsor ID
- TCM for lung adenocarcinoma
- Conditions
- Lung Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 23 Jul 2020 (actual)
- 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 is to evaluate the efficacy and safety of Jin-yuan-kang granule in the treatment of lung adenocarcinoma (LUAD) preliminarily, and provide reference for further study.
Detailed description
Lung adenocarcinoma (LUAD) is a type of non-small cell lung cancer (NSCLC) with a rapid disease progression and poor treatment effect. The LUAD patients have a short median survival time with 8-11 months. Up to now, chemotherapy is still the first-line treatment for LUAD. PC protocol (pemetrexed + cisplatin) is most commonly used, which is also recommended by NCCN guidelines. However, critical side effects have limited the application and efficacy. Patients will undergo poor quality of life, and the disease will progress rapidly. We still face the stern situation for the treatment of LUAD. It is urgent to develop new treatment and management strategies. Our previous study showed that jing-yuan-kang granule has certain curative effect on LUAD.
This is a multi-certers, randomized, controlled clinical trial to assess the efficacy and safety of Jing-yuan-kang granule in improving quality of life for LUAD patients. After a 2-week wash-out period, a total of 144 LUAD patients will be randomly assigned into experimental or control group with a ratio of 1:1. On the basis of that all the participants will receive PC chemotherapy and symptomatic treatment, the patients in the experimental group will receive jing-yuan-kang granule with no other treatments for control group. The primary outcome is quality of life. The secondary outcomes include Karnofsky (KPS) scores, clinical symptoms, and change of tumor volume. Safety and adverse events will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Jing-yan-kang Granule, Drug: PC chemotherapy and symptomatic treatmentOn the basis of PC chemotherapy and symptomatic treatment, the patients in the experimental group will receive jing-yuan-kang granule with one dose daily. |
| Control Group | Other | Drug: PC chemotherapy and symptomatic treatmentAll the patients in control group will receive PC chemotherapy and symptomatic treatment without other treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A confirmed diagnosis of LADC.
- Age ranges from17years to75years.
- A KPS score ≥40.
- Without radiotherapy, immunotherapy and targeted therapy.
- Without participanting in any other trial.
Key exclusion criteria (5 listed)
- Pregnant, nursing or may become pregnant women.
- The patient has a history of allergy to any of the components of the intervention drug;
- Patients with severe liver and kidney dysfunction, cardiovascular and cerebrovascular diseases.
- Unconscious or unable to communicate normally.
- Patients with poor compliance.
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 |
|---|---|---|
| Jing-yan-kang GranuleJing-yuan-kang granule will be administered 6 days on and 1 days off for 12weeks. | Drug | Experimental Group |
| PC chemotherapy and symptomatic treatmentDrugs used in PC chemotherapy includes Pemetrexed and Cisplatin. Pemetrexed disodium for injection 500 mg per square meter, intravenous drip on day 1 in each treatment cycle. Cisplatin injection 75 mg per square meter, intravenous drip from day 1 to day 3 in each treatment cycle. One treatment cycle will be continued for 21 days and 4 cycles will be performed. If necessary, symptomatic treatment will also be used. | Drug | Control Group, Experimental Group |
Primary outcome
The quality of life will be evaluated by The European Organization for Research and Treatment of Cancer Quality of life Questinnaire Core-30(EORTC QLQ-C30) scale
Time frame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
A score of 1-4 will be administrated for each item in EORTC QLQ-C30 . The higher scores will indicate the worse outcomes.
Quality of life will be evaluated by Quality of life Questinnaire Lung Cancer-13(QLQ-LC13)
Time frame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
A score of 1-4 will be administrated for each item in QLQ-LC13. The higher scores will indicate the worse outcomes.
4 secondary outcomes
Karnofsky(KPS) scores
Time frame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
TCM syndrome index
Time frame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
Change of tumor volume
Time frame: Change at 12 weeks after treatment compared to baseline.
Adverse events will be evaluated and recorded at any time.
Time frame: at baseline, up to 6 weeks and 12 weeks after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Jing-yan-kang Granule and PC chemotherapy and symptomatic treatment in people with Lung Adenocarcinoma, run by Henan University of Traditional Chinese Medicine.
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 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 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan-dan Wei (+8613849186250, 1617924593@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of life will be evaluated by The European Organization for Research and Treatment of Cancer Quality of life Questinnaire Core-30(EORTC QLQ-C30) scale (time frame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.). 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 23 Jul 2020.