Chemotherapy Combined With Yangzhengxiaoji Capsule in Patients With Advanced Non-Small Cell Lung Cancer

Phase 4

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Placebo Capsule; Drug: Yangzhengxiaoji Capsule

• Registration Number: NCT02195453
• Lead Sponsor: Shandong Cancer Hospital and Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-07
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-17
• Last Update Submitted: 2014-07-17
• Study First Posted: 2014-07-21
• Last Update Posted: 2014-07-21
• Study Start: 2014-08
• Primary Completion: 2016-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Capsule	Placebo Capsule	Gemcitabine or Pemetrexed Cisplatin Placebo Capsule four granules t.i.d po
Yangzhengxiaoji Capsule	Yangzhengxiaoji Capsule	Gemcitabine or Pemetrexed Cisplatin Yangzhengxiaoji Capsule four granules t.i.d po

Primary Outcome Measures

Name	Time	Method
Lung Cancer Symptom Scale	84day
Functional Assessment of Cancer Therapy-Lung scale	84day

Secondary Outcome Measures

Name	Time	Method
Completion of chemotherapy	84 day
Progression-free survival	84 day
Anti-cancer drugs common grading evaluation of adverse reaction	84day
Objective response rate	84day