QYJD Compound Preparation Promotes Rapid Postoperative Recovery in Early-stage NSCLC Patients by Regulating Tissue Microecology: a Prospective, Randomized Controlled, Open-label, Phase I Clinical Study With Predefined Future Exploration

January 4, 2025 updated by: Fuzhou General Hospital
QYJD compound preparation has the efficacy of clearing heat and removing toxins, dispelling blood stasis and relieving pain, etc. investigators aimed to explore the effect of expelling blood stasis and removing toxins compound preparation on the microecological changes of lungs of patients with early stage non-small cell lung cancer (NSCLC) by using metagenomics next-generation sequencing (mNGS) technology to carry out a prospective phase I clinical study. The aim of the study was to investigate the effect of the expelling stasis and detoxifying compound preparation on the microecology of lungs of patients with early-stage non-small cell lung cancer (NSCLC), and to conduct a prospective phase I clinical study to provide new ideas for promoting the postoperative rehabilitation of early-stage NSCLC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. participants screened for eligibility should sign the appropriate Informed Consent Form (ICF) prior to completing any study procedures.
  2. The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fuzhou
      • Fujian, Fuzhou, China, 350025
        • Zongyang Yu

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Study Population Patients diagnosed with early-stage non-small cell lung cancer in accordance with the Primary Lung Cancer Diagnosis and Treatment Guidelines (2022 Edition) issued by the National Health and Health Commission and the TNM staging criteria of the 8th edition of the International Association for the Study of Lung Cancer (IASLC).

Inclusion criteria:

  1. Patients with (a) no contraindications to surgery, early stage NSCLC diagnosed by postoperative pathology, and clinical stage I-IIIA; (b) aged 18-80 years old, with KPS score ≥60; (c) with expected survival of more than 3 months; (d) with no history of smoking; (e) with no previous underlying lung diseases such as bronchiectasis, bronchial asthma, or COPD; (f) without neoadjuvant chemotherapy; (g) with no previous treatment with neoadjuvant chemotherapy; (h) with no previous treatment with neoadjuvant chemotherapy; (i) with no previous treatment with bronchodilatation, bronchial asthma, or COPD; (j) with no previous treatment with neoadjuvant chemotherapy. (f) No neoadjuvant chemotherapy; (g) No history of other systemic malignancies; (h) Sufficient fresh tumor tissue specimens are available.
  2. Participants are willing to participate in this study and comply with the study plan;
  3. Participants or legally authorized representatives were able to provide written informed consent approved by the ethical review board managing the site.

Exclusion Criteria:

  1. the presence of malignant tumors or metastatic foci in other parts of the body;
  2. the combination of other organic diseases;
  3. psychiatric disorders or communication disorders;
  4. lung infections, systemic hematologic diseases, immune system diseases;
  5. bronchodilatation, bronchial asthma, or chronic obstructive pulmonary disease and other underlying lung diseases;
  6. within the past month, there are antibiotics, immunosuppressive drugs, hormones, probiotics, as well as any those who have taken antibiotics, immunosuppressants, hormones, probiotics, and any form of traditional Chinese medicine or proprietary Chinese medicine within the past month;
  7. Those who have a history of smoking;
  8. Those who have a history of occupational or environmental exposure to dust, mines, or asbestos.

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
Intervention / Treatment
No Intervention: Blank control group
Group1 There was no oral drug treatment before surgery. Patients were treated with anti-inflammatory and analgesic therapy postoperatively on a case-by-case basis.
Experimental: QYJD Compound Preparation intervention group
Group2 In the treatment group, the patients were orally treated with expelling blood stasis and detoxifying compound preparation for 4 days before thoracoscopic radical lung cancer surgery, 2 capsules (0.3g/capsule) at a time, 3 times a day, with lukewarm water, for a total of 4 days.Patients were treated with anti-inflammatory and analgesic therapy postoperatively on a case-by-case basis.
Drug: QYJD Compound Preparation
The intervention group was treated with 2 capsules (g) of expelling stasis and QYJD compound preparation orally for 4 days before thoracoscopic radical surgery for lung cancer, 3 times a day. The blank control group had no oral drug treatment before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rapid rehabilitation indexes
Time Frame: 15 days
the number of days of postoperative chest drain retention
15 days
Rapid rehabilitation indexes
Time Frame: 1 week
postoperative pain VAS scores
1 week
Rapid rehabilitation indexes
Time Frame: 7 day
six-minute walking experiments
7 day
Laboratory indicators of inflammation
Time Frame: through study completion, an average of 1 year
including white blood cell count, neutrophil count, lymphocyte count, platelet count, NLR, PLR
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Fuzhou General Hospital

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 (Actual)

December 8, 2021

Primary Completion (Actual)

December 8, 2022

Study Completion (Actual)

December 8, 2023

Study Registration Dates

First Submitted

November 15, 2024

First Submitted That Met QC Criteria

January 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 4, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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