TCM in the Treatment of Lung Adenocarcinoma

July 18, 2020 updated by: Henan University of Traditional Chinese Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
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.
Drug: Jing-yan-kang Granule
Jing-yuan-kang granule will be administered 6 days on and 1 days off for 12weeks.
Drug: PC chemotherapy and symptomatic treatment

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.
Other: Control Group
All the patients in control group will receive PC chemotherapy and symptomatic treatment without other treatment.
Drug: PC chemotherapy and symptomatic treatment

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Karnofsky(KPS) scores
Time Frame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
Physical conditions will be evaluated by KPS scores with a score of 0-100. A higher score will indicate a better physical conditon.
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.
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.
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.
Change of tumor volume will be assessed by the length of longest diameter. The longger diameter will indicate worse disease.
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.
Safety
at baseline, up to 6 weeks and 12 weeks after treatment.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henan University of Traditional Chinese Medicine

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TCM for lung adenocarcinoma

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Lung Adenocarcinoma

Clinical Trials on Jing-yan-kang Granule

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings