Shenlingcao Oral Liquid for Patients With Stage II or IIIA NSCLC

NCT03712969 | Completed Phase 4 DMC

• 1 other identifier: 20181009
• Study Type: interventional
• Target: 527
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung; Chemotherapy, Adjuvant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The completion rate of chemotherapy

  2-3 days after the fourth chemotherapy cycle

• Disease-free survival

  24 months after enrollment

• Remission of hematological toxicity caused by chemotherapeutic drugs

  2-3 days after the fourth chemotherapy cycle

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients receive conventional adjuvant chemotherapy.

Interventions

Shenlingcao Oral Liquid DRUG

Patients receive Shenlingcao oral liquid combined with conventional adjuvant chemotherapy, which take 4 courses, 30 days per course, one bottle per day.

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• Liu Y, Luo X, Liu J, Ma Y, Tan J, Wang W, Hu J, Fu X, Xu L, Yu F, Xu S, Ma H, Yu X, You Q, Wang Z, Li L, Zhang X, Sun X. Shenlingcao oral liquid for patients with non-small cell lung cancer receiving adjuvant chemotherapy after radical resection: A multicenter randomized controlled trial. Phytomedicine. 2023 May;113:154723. doi: 10.1016/j.phymed.2023.154723. Epub 2023 Feb 21.

  PMID: 36871476 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xin Sun, PhD

  The West China Hospital of Sichuan university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 19, 2018
• Study Start: November 5, 2018
• Primary Completion: March 14, 2022
• Study Completion: May 4, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)