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

NCT06766565 | Completed Phase 1 DMC

• 1 other identifier: 2021-026
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NSCLC

Keywords

QYJD Compound Preparation; clinical trials; rapid rehabilitation; lung tissue microecology

Outcome Measures

Primary Outcomes (4)

• Rapid rehabilitation indexes

  the number of days of postoperative chest drain retention

  15 days

• Rapid rehabilitation indexes

  postoperative pain VAS scores

  1 week

• Rapid rehabilitation indexes

  six-minute walking experiments

  7 day

• Laboratory indicators of inflammation

  including white blood cell count, neutrophil count, lymphocyte count, platelet count, NLR, PLR

  through study completion, an average of 1 year

Study Arms (2)

Blank control group

NO INTERVENTION

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.

QYJD Compound Preparation intervention group

EXPERIMENTAL

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

Interventions

QYJD Compound Preparation DRUG

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.

QYJD Compound Preparation intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants are willing to participate in this study and comply with the study plan;
• Participants or legally authorized representatives were able to provide written informed consent approved by the ethical review board managing the site.

You may not qualify if:

• the presence of malignant tumors or metastatic foci in other parts of the body;
• the combination of other organic diseases;
• psychiatric disorders or communication disorders;
• lung infections, systemic hematologic diseases, immune system diseases;
• bronchodilatation, bronchial asthma, or chronic obstructive pulmonary disease and other underlying lung diseases;
• 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;
• Those who have a history of smoking;
• Those who have a history of occupational or environmental exposure to dust, mines, or asbestos.

Sponsors & Collaborators

• Fuzhou General Hospital: lead

Study Sites (1)

Zongyang Yu

Fujian, Fuzhou, 350025, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: January 9, 2025
• Study Start: December 8, 2021
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2023
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

CN (1)