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 | Terminated

• 1 other identifier: 320.6750.17576
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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)

  About 20 minutes

Study Arms (2)

Exposure group

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

Control group patients are those who voluntarily choose not to use Shenlingcao Oral Liquid recommended by the doctor in NSCLC patients receiving adjuvant chemotherapy.

Interventions

Shenlingcao Oral Liquid DRUG

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.

Exposure group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing adjuvant radiotherapy or chemotherapy for Stage II and IIIA Non-small Cell Lung Cancer After Radical Resection

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, 300051, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xin Sun

  The Chinese Cochrane Center，West China Hospital, Sichuan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 27, 2018
• Study Start: March 28, 2018
• Primary Completion: September 10, 2018
• Study Completion: September 10, 2018
• Last Updated: August 26, 2019

Record last verified: 2019-08

Locations

CN (1)