Carcinoma, Non-Small-Cell Lung, Chemotherapy, Adjuvant
Conditions
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.
Interventions
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.
Sponsors
West China Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Outcome results
None listed