NCT04482829

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

July 3, 2020

Last Update Submit

July 18, 2020

Conditions

Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.

Secondary Outcomes (4)

  • Karnofsky(KPS) scores

    Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.

  • TCM syndrome index

    Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.

  • Change of tumor volume

    Change at 12 weeks after treatment compared to baseline.

  • Adverse events will be evaluated and recorded at any time.

    at baseline, up to 6 weeks and 12 weeks after treatment.

Study Arms (2)

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.

Drug: Jing-yan-kang GranuleDrug: PC chemotherapy and symptomatic treatment

Control Group

OTHER

All the patients in control group will receive PC chemotherapy and symptomatic treatment without other treatment.

Drug: PC chemotherapy and symptomatic treatment

Interventions

Jing-yan-kang GranuleDRUG

Jing-yuan-kang granule will be administered 6 days on and 1 days off for 12weeks.

Experimental Group
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.

Control GroupExperimental Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Central Study Contacts

Dan-dan Wei

CONTACT

+86138491862501617924593@qq.com

Shi-qing Jiang

CONTACT

+8613607640006jiangshiqing66@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2020

First Posted

July 23, 2020

Study Start

September 15, 2020

Primary Completion

December 30, 2020

Study Completion

June 30, 2022

Last Updated

July 23, 2020

Record last verified: 2020-07