Shenlingcao Oral Liquid for Patients With Stage II or IIIA Non-small Cell Lung Cancer Receiving Radical Resection: A Pragmatic, Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 527
- 试验地点
- 1
- 主要终点
- The quality of life assessed by Research and Treatment of Cancer Quality of Life Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention group
Patients receive Shenlingcao oral liquid combined with conventional adjuvant chemotherapy, which take 4 courses, 30 days per course, one bottle per day.
干预措施: Shenlingcao Oral Liquid (Drug)
结局指标
主要结局
The quality of life assessed by Research and Treatment of Cancer Quality of Life Questionnaire
时间窗: 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.
次要结局
- The completion rate of chemotherapy(2-3 days after the fourth chemotherapy cycle)
- Remission of hematological toxicity caused by chemotherapeutic drugs(2-3 days after the fourth chemotherapy cycle)
- Disease-free survival(24 months after enrollment)