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

No results posted yet for this study

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

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

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03578575 on ClinicalTrials.gov