Shenlingcao Oral Liquid for Patients With Stage II or IIIA NSCLC

Shenlingcao Oral Liquid for Patients With Stage II or IIIA Non-small Cell Lung Cancer Receiving Radical Resection: A Pragmatic, Multicenter Randomized Controlled Trial

In this study, a pragmatic, open labelled, multi-center randomized controlled trial will be conducted. The study population are stage II and IIIA NSCLC patients undergoing R0 resection and will be scheduled for adjuvant chemotherapy. Potentially eligible patients will be screened by the research clinicians and requested to complete and sign a consent form before enrolment. Eligible patients who consent to participate will be randomly assigned to the intervention group (patients receive conventional treatment and Shenlingcao oral liquid) and the control group (patients only receive conventional treatment) designed dynamic stratified block randomized algorithm via a central randomization system for clinical research using 1:1 ratio.

The intervention and control group will be enrolled before the first chemoradiation. Non-allelic follow-up will be conducted in this study and terminated when the last enrolled patient follow up to 24 months. Prospectively collected information from patients, including baseline, chemoradiation, use of Shenlingcao Oral Liquid and the other complementary drugs, and various outcome measures (the questionnaire of EORTC QLQ, death, tumor recurrence, tumor metastasis, and chemotherapy-induced side effects of the blood system, etc.). Follow-up points included: Baseline (before giving chemotherapy), 2-3 days after each chemotherapy cycle, and 6,12,18,24,30,36 months after enrollment.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung; Chemotherapy, Adjuvant
• Intervention / Treatment: Drug: Shenlingcao Oral Liquid

• Study Type: Interventional
• Enrollment (Actual): 527
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 or older;
• Pathological diagnosis of patients with stage II, III A primary NSCLC;
• R0 resection has been accepted;
• Received adjuvant chemotherapy or adjuvant chemotherapy for the first time after surgery;
• Informed consent has been signed.

Exclusion Criteria:

• Incorporation of other malignant tumors (such as leukemia, liver cancer, etc.);
• Patients with unclear pathological types;
• Patients with unclear pathological staging;
• Preserved Shenlingcao Oral Liquid before R0 resection surgery;
• Received immunotherapy or targeted therapy before R0 resection surgery;
• Radiotherapy and chemotherapy before R0 resection surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Patients receive Shenlingcao oral liquid combined with conventional adjuvant chemotherapy, which take 4 courses, 30 days per course, one bottle per day.	Drug: Shenlingcao Oral Liquid; Patients receive Shenlingcao oral liquid combined with conventional adjuvant chemotherapy, which take 4 courses, 30 days per course, one bottle per day.
No Intervention: Control group; Patients receive conventional adjuvant chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quality of life assessed by Research and Treatment of Cancer Quality of Life Questionnaire	We investigated the long-term quality of life of postoperative lung cancer patients, utilizing the disease-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ) C30 to assess the quality of life among these patients. The EORTC QLQ-C30 is composed of 9 multi-item scales including 5 functional scales, 3 symptom scales, a global quality-of-life scale, and 6 single-item symptom measures. All the items are scored on a scale of 0 to 100, with a high score on a functional or the global quality-of-life scale representing a high level of functioning or quality of life and a high score on a symptom scale representing a high level of symptoms.	2-3 days after the fourth chemotherapy cycle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The completion rate of chemotherapy	Whether the patient completed four cycles of chemotherapy.	2-3 days after the fourth chemotherapy cycle
Disease-free survival	Disease-free survival (DFS) refers to the time from the operation to the time that there is evidence of tumor recurrence / metastasis or any cause of death (the DFS of lost follow-up patients is the last follow-up time). The tumor recurrence / metastasis needs to be diagnosed based on imaging or pathological evidence.	24 months after enrollment
Remission of hematological toxicity caused by chemotherapeutic drugs	Remission of hematological toxicity caused by chemotherapeutic drugs, using WHO grading of acute and subacute toxicity. Hematological toxicity is observed from four hematological indicators, including hemoglobin, white blood cells, granulocytes and platelets. A 5-grade system of severity levels is recommended for general use: grades 0-4 . The higher the level, the greater the toxic reaction. The most severe of the four indicators is the patient's hematological toxicity level.	2-3 days after the fourth chemotherapy cycle

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Director: Xin Sun, PhD, The West China Hospital of Sichuan University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Actual): March 14, 2022
• Study Completion (Actual): May 4, 2023

Study Registration Dates

• First Submitted: October 9, 2018
• First Submitted That Met QC Criteria: October 18, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 20181009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No