NCT02195453
Unknown
Phase 4
A Randomized,Double-blind,Placebo-Controlled,Multicenter Clinical Trail of Chemotherapy Combined With Yangzhengxiaoji Capsule in Patients With Advanced Non-Small Cell Lung Cancer
Shandong Cancer Hospital and Institute0 sites520 target enrollmentAugust 2014
ConditionsNon-Small Cell Lung Cancer
Overview
- Phase
- Phase 4
- Intervention
- Yangzhengxiaoji Capsule
- Conditions
- Non-Small Cell Lung Cancer
- Sponsor
- Shandong Cancer Hospital and Institute
- Enrollment
- 520
- Primary Endpoint
- Lung Cancer Symptom Scale
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to observe quality of life and treatment side effects in patients with advanced non small cell lung cancer (NSCLC) receive chemotherapy and Yangzhengxiaoji capsule.
Investigators
Jinming Yu
Shandong Cancer Hospital and Institute
Shandong Cancer Hospital and Institute
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Yangzhengxiaoji Capsule
Gemcitabine or Pemetrexed Cisplatin Yangzhengxiaoji Capsule four granules t.i.d po
Intervention: Yangzhengxiaoji Capsule
Placebo Capsule
Gemcitabine or Pemetrexed Cisplatin Placebo Capsule four granules t.i.d po
Intervention: Placebo Capsule
Outcomes
Primary Outcomes
Lung Cancer Symptom Scale
Time Frame: 84day
Functional Assessment of Cancer Therapy-Lung scale
Time Frame: 84day
Secondary Outcomes
- Completion of chemotherapy(84 day)
- Progression-free survival(84 day)
- Anti-cancer drugs common grading evaluation of adverse reaction(84day)
- Objective response rate(84day)
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