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Shenlingcao Oral Liquid for Patients With Stage II or IIIA NSCLC

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ClinicalTrials.gov Identifier: NCT03712969
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Sun Xin, West China Hospital

Brief Summary:

In this study, a pragmatic, open labelled, multi-center randomized controlled trial will be conducted. The study population are stage II and IIIA NSCLC patients undergoing R0 resection and will be scheduled for adjuvant chemotherapy. Potentially eligible patients will be screened by the research clinicians and requested to complete and sign a consent form before enrolment. Eligible patients who consent to participate will be randomly assigned to the intervention group (patients receive conventional treatment and Shenlingcao oral liquid) and the control group (patients only receive conventional treatment) designed dynamic stratified block randomized algorithm via a central randomization system for clinical research using 1:1 ratio.

The intervention and control group will be enrolled before the first chemoradiation. Non-allelic follow-up will be conducted in this study and terminated when the last enrolled patient follow up to 24 months. Prospectively collected information from patients, 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 Phase
Carcinoma, Non-Small-Cell Lung Chemotherapy, Adjuvant Drug: Shenlingcao Oral Liquid Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1096 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Shenlingcao Oral Liquid for Patients With Stage II or IIIA Non-small Cell Lung Cancer Receiving Radical Resection: A Pragmatic, Multicenter Randomized Controlled Trial
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Patients receive Shenlingcao oral liquid combined with conventional adjuvant chemotherapy, which take 4 courses, 30 days per course, one bottle per day.
Drug: Shenlingcao Oral Liquid
Patients receive Shenlingcao oral liquid combined with conventional adjuvant chemotherapy, which take 4 courses, 30 days per course, one bottle per day.

No Intervention: Control group
Patients receive conventional adjuvant chemotherapy.



Primary Outcome Measures :
  1. The quality of life assessed by Research and Treatment of Cancer Quality of Life Questionnaire [ Time Frame: 2-3 days after the fourth chemotherapy cycle ]
    We investigated the long-term quality of life of postoperative lung cancer patients, utilizing the disease-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ) C30 to assess the quality of life among these patients. The EORTC QLQ-C30 is composed of 9 multi-item scales including 5 functional scales, 3 symptom scales, a global quality-of-life scale, and 6 single-item symptom measures. All the items are scored on a scale of 0 to 100, with a high score on a functional or the global quality-of-life scale representing a high level of functioning or quality of life and a high score on a symptom scale representing a high level of symptoms.

  2. Remission of hematological toxicity caused by chemotherapeutic drugs [ Time Frame: 2-3 days after the fourth chemotherapy cycle ]
    Remission of hematological toxicity caused by chemotherapeutic drugs, using WHO grading of acute and subacute toxicity. Hematological toxicity is observed from four hematological indicators, including hemoglobin, white blood cells, granulocytes and platelets. A 5-grade system of severity levels is recommended for general use: grades 0-4 . The higher the level, the greater the toxic reaction. The most severe of the four indicators is the patient's hematological toxicity level.


Secondary Outcome Measures :
  1. The completion rate of chemotherapy [ Time Frame: 2-3 days after the fourth chemotherapy cycle ]
    Whether the patient completed four cycles of chemotherapy.

  2. Disease-free survival [ Time Frame: 24 months after enrollment ]
    Disease-free survival (DFS) refers to the time from the operation to the time that there is evidence of tumor recurrence / metastasis or any cause of death (the DFS of lost follow-up patients is the last follow-up time). The tumor recurrence / metastasis needs to be diagnosed based on imaging or pathological evidence.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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): NCT03712969


Contacts
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Contact: Xin Sun, PhD +86 18980606047 sunx79@hotmail.com

Locations
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China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430030
Contact: Xiangning Fu, MD         
Sponsors and Collaborators
West China Hospital
Investigators
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Study Director: Xin Sun, PhD The West China Hospital of Sichuan university

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Responsible Party: Sun Xin, Director, West China Hospital
ClinicalTrials.gov Identifier: NCT03712969     History of Changes
Other Study ID Numbers: 20181009
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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