To Investigate the Molecular Mechanism of Traditional Chinese Medicine Constitution Using Next-generation Sequencing in Nasopharyngeal Carcinoma
NCT03578575 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2018-07-30
Summary
To investigate the molecular mechanism of traditional Chinese medicine constitution, the investigators proposed a randomized, double-blind, placebo-controlled, phase II trial to recruit 120 patients with nasopharyngeal cancer. Next generation sequencing, immune repertoire, gut microbiota, traditional Chinese medicine constitution and tongue diagnosis would be examined before/after 16 weeks of treatment of Danggui Buxue Tang from the beginning of concurrent chemoradiotherapy in this project. The correlation between different examinations would be analyzed to investigate the molecular mechanism of traditional Chinese medicine constitution. Disease survival, recurrence, and quality of life would be also followed up for two years to evaluate the benefit of Danggui BuxueTang.
Conditions
- Nasopharyngeal Carcinoma
Interventions
- DRUG
-
Danggui Buxue Tang
Danggui Buxue Tang is an extracted powder of traditional Chinese medicine formula.
- DRUG
-
Placebo is a very low dose Danggui Buxue Tang powder.
Sponsors & Collaborators
-
China Medical University Hospital
lead OTHER
Principal Investigators
-
Hen-Hong Chang, Ph.D. · China Medical University, China
-
Han-Kuei Wu, Ph.D. · China Medical University, China
-
Kun San Chao, M.D. · China Medical University, China
-
Eric Y. Chuang, Ph.D. · National Taiwan University
-
Ming-Hsui Tsai, M.D. · China Medical University, China
-
Yu-Chuen Huang, Ph.D. · China Medical University, China
-
Chia-Hao Chang, M.M.S. · China Medical University, China
-
Yao-Ching Wang, M.M.S. · China Medical University, China
-
Chun-Hung Hua, M.D. · China Medical University, China
-
Shih-Neng Yang, M.D. · China Medical University, China
-
Ying-Chun Lin, M.D. · China Medical University, China
-
Ti-Hao Wang, M.D. · China Medical University, China
-
Ching Yun Hsieh, M.D. · China Medical University, China
-
Ming-Yu Lien, M.D. · China Medical University, China
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-26
- Primary Completion
- 2020-07-31
- Completion
- 2020-07-31
Countries
- Taiwan
Study Locations
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