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
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|ClinicalTrials.gov Identifier: NCT03479294|
Recruitment Status : Terminated (Because of the difficulty of research operation, we changed to another research design.)
First Posted : March 27, 2018
Last Update Posted : August 26, 2019
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.
|Condition or disease||Intervention/treatment|
|Carcinoma, Non-Small-Cell Lung Chemotherapy, Adjuvant||Drug: Shenlingcao Oral Liquid|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||9 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||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|
|Actual Study Start Date :||March 28, 2018|
|Actual Primary Completion Date :||September 10, 2018|
|Actual Study Completion Date :||September 10, 2018|
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.
Drug: Shenlingcao Oral Liquid
Shenlingcao Oral Liquid is a health product, and its main components are American ginseng, lucidum, Cordyceps fermented powder Cs-4, rose, maltitol and water. Shenlingcao Oral Liquid can relieve physical fatigue and enhance immunity.
Control group patients are those who voluntarily choose not to use Shenlingcao Oral Liquid recommended by the doctor in NSCLC patients receiving adjuvant chemotherapy.
- The quality of life [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479294
|Tianjin Chest Hospital|
|Tianjin, Tianjin, China, 300051|
|Principal Investigator:||Xin Sun||The Chinese Cochrane Center，West China Hospital, Sichuan University|