Clinical trial NCT03578575: To Investigate the Molecular Mechanism of Traditional Chinese Medicine Constitution Using Next-generation Sequencing in Nasopharyngeal Carcinoma
Official title: To Investigate the Molecular Mechanism of Traditional Chinese Medicine Constitution Using Next-generation Sequencing in Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma
Concurrent chemo-radiotherapy
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 120 subjects are divided into experimental group and control group (placebo).
Primary purpose: TREATMENT

Brief 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.

Detailed description: The basis for academic excellence is the interdisciplinary cooperation. The individualized medicine is the future trends, and the theory of body constitution is the most potential study for the individualized medicine and to research the process and prognosis of disease. Technique of next-generation sequencing (NGS) is also involved to comprehend to the mechanism of the prescriptions under the theory of body constitution.

The nasopharyngeal cancer is a Chinese-specific disease, and radiation therapy has remarkable effect. There are many studies proving that Traditional Chinese medication can relieve the side effect of radiation therapy. The study will combine next-generation sequencing and TCM diagnostic tool, and analyze the transformation of body constitution and the performance of genes related to radiation therapy. The results may reveal the molecular mechanism of TCM constitutions and the benefit of Danggui BuxueTang, and may be used for early screen and prevention to other cancers or diseases. Furthermore, it can help to develop the potential drugs.

The study plans to collect 120 cases within two years. The participants would be divided randomly to the experimental group and control group. The blood sample would be taken for next generation sequencing analysis before the radiation therapy, and after the radiation therapy combined with traditional Chinese medication. The result of samples would be compared with each other to identify "Qi deficiency gene" and "TCM effective gene".

Eligibility criteria: Inclusion Criteria:

Patients with pathological diagnosis of nasopharyngeal carcinoma stage II \~ IVa (AJCC eighth edition) preparing to receive concurrent chemoradiotherapy

Exclusion Criteria:

* Pregnant or lactating women
* ECOG PS (ECOG performance status) scores of over 2 points for each day's performance assessment
* Take anticoagulants or antiplatelet agents such as aspirin, warfarin, etc.
* Cannot accept routine treatment, or can not cooperate with the research program

Primary outcomes:
measure: The correlation between next-generation sequencing analysis and traditional Chinese medicine constitution
timeFrame: The biomarker as assessed by Next-generation sequencing analysis, Change from baseline in the gene expression at 16 weeks of treatment of Danggui Buxue Tang from the beginning of concurrent chemoradiotherapy and 2-year follow-up.
Secondary outcomes:
measure: The quality of life as assessed by the score of questionnaire of European Organisation for Research and Treatment of Cancer C30
timeFrame: Change from baseline in score of questionnaire at 16 weeks of treatment of Danggui Buxue Tang from the beginning of concurrent chemoradiotherapy and 2-year follow-up.
measure: The quality of life as assessed by the score of questionnaire of European Organisation for Research and Treatment of Cancer H&N35
timeFrame: Change from baseline in score of questionnaire at 16 weeks of treatment of Danggui Buxue Tang from the beginning of concurrent chemoradiotherapy and 2-year follow-up.
measure: Survival rate
timeFrame: throughout the study, an average of 2 year
measure: Disease recurrence
timeFrame: throughout the study, an average of 2 year
measure: Next-generation sequencing
timeFrame: pre-treatment and after 16 weeks of treatment
measure: Immune repertoire
timeFrame: pre-treatment and after 16 weeks of treatment
measure: Microbiota
timeFrame: pre-treatment and after 16 weeks of treatment
measure: Tongue diagnosis
timeFrame: pre-treatment and after 16 weeks of treatment
measure: Constitution in Chinese Medicine Questionnaire (CCMQ)
timeFrame: Change from baseline in score of questionnaire at 16 weeks of treatment of Danggui Buxue Tang from the beginning of concurrent chemoradiotherapy and 2-year follow-up.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University, China
name: Hen-Hong Chang, Ph.D.
role: STUDY_CHAIR
affiliation: China Medical University, China
name: Han-Kuei Wu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University, China
name: Kun San Chao, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University
name: Eric Y. Chuang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University, China
name: Ming-Hsui Tsai, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University, China
name: Yu-Chuen Huang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University, China
name: Chia-Hao Chang, M.M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University, China
name: Yao-Ching Wang, M.M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University, China
name: Chun-Hung Hua, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University, China
name: Shih-Neng Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University, China
name: Ying-Chun Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University, China
name: Ti-Hao Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University, China
name: Ching Yun Hsieh, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University, China
name: Ming-Yu Lien, M.D.
role: PRINCIPAL_INVESTIGATOR
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