Real-World Study on Adjuvant Therapy Combined With Shenlingcao Oral Liquid in Patients for Stage II and IIIA Non-small Cell Lung Cancer After Radical Resection

Terminated

• Conditions: Carcinoma, Non-Small-Cell Lung; Chemotherapy, Adjuvant
• Interventions: Drug: Shenlingcao Oral Liquid

• Registration Number: NCT03479294
• Lead Sponsor: West China Hospital

Brief Summary

This study will establish a multi-center, prospective registration database. The included population are stage II and IIIA NSCLC patients undergoing R0 resection and will be scheduled for adjuvant chemotherapy. Before the first adjuvant chemotherapy, under the recommendation of a doctor, patients will voluntarily choose to use (exposed group) or not to use (control group) Shenlingcao Oral Liquid, which donated by Jiangzhong Group for 30 bottles. The research centers need to be consecutively enrolled patients according to the allocation of the number of cases according to the ratio of 3: 1 in exposure group and control group.

The exposed and control groups will be followed up to 36 months (non-allelic follow-up). Information from patients will be prospectively collected, 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-03-23
• Study First Posted: 2018-03-27
• Study Start: 2018-03-28
• Primary Completion: 2018-09-10
• Study Completion: 2018-09-10
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposure group	Shenlingcao Oral Liquid	Exposure group patients are those who voluntarily choose to use Shenlingcao Oral Liquid recommended by the doctor in NSCLC patients receiving adjuvant chemotherapy. Jiangzhong Group will donate the first 30 bottles of medicine, and afterwards, patients may purchase if they still need to take it. The length of time and dose of Shenlingcao Oral Liquid are unlimited and other adjunctive treatments may be used at the same time.

Primary Outcome Measures

Name	Time	Method
The quality of life	About 20 minutes	A scale for the quality of life of cancer patients developed by the European Organization for Research and Treatment (according to EORTC QLQ-C30 V3.0)

Trial Locations

Locations (1)

Tianjin Chest Hospital; 🇨🇳 Tianjin, Tianjin, China