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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Sun Xin, West China Hospital

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.


Condition or disease Intervention/treatment
Carcinoma, Non-Small-Cell Lung Chemotherapy, Adjuvant Drug: Shenlingcao Oral Liquid

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Study Type : Observational [Patient Registry]
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

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


Locations
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China, Tianjin
Tianjin Chest Hospital
Tianjin, Tianjin, China, 300051
Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Xin Sun The Chinese Cochrane Center,West China Hospital, Sichuan University

Additional Information:

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Responsible Party: Sun Xin, Director, West China Hospital
ClinicalTrials.gov Identifier: NCT03479294    
Other Study ID Numbers: 320.6750.17576
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases