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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

NCT03479294 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2019-08-26

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Xin Sun · The Chinese Cochrane Center，West China Hospital, Sichuan University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-28
Primary Completion
2018-09-10
Completion
2018-09-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03479294 on ClinicalTrials.gov