An observational study in Carcinoma, Non-Small-Cell Lung and Chemotherapy, Adjuvant, sponsored by West China Hospital. Terminated at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-26.
Sponsored by West China Hospital · Observational
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.
Patients undergoing adjuvant radiotherapy or chemotherapy for Stage II and IIIA Non-small Cell Lung Cancer After Radical Resection
Exclusion Criteria:
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
Control group patients are those who voluntarily choose not to use Shenlingcao Oral Liquid recommended by the doctor in NSCLC patients receiving adjuvant chemotherapy.
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.
The quality of life
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)
Time frame: About 20 minutes
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
West China Hospital