To Investigate the Molecular Mechanism of Traditional Chinese Medicine Constitution Using Next-generation Sequencing in Nasopharyngeal Carcinoma

July 26, 2018 updated by: China Medical University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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".

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 404
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Hen-Hong Chang, M.D., Ph.D.
          • Phone Number: 3501 +886-4-22053366
          • Email: tcmchh55@gmail.com
        • Contact:
          • Ching-Mao Chang, M.D.
          • Phone Number: 886
        • Principal Investigator:
          • Hen-Hong Chang, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Danggui Buxue Tang group
Use Danggui Buxue Tang 5g/time, 3 times a day, for 12 weeks.
Drug: Danggui Buxue Tang
Danggui Buxue Tang is an extracted powder of traditional Chinese medicine formula.
Placebo Comparator: Placebo group
Use Placebo 5g/time, 3 times a day, for 12 weeks.
Drug: Placebo
Placebo is a very low dose Danggui Buxue Tang powder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation between next-generation sequencing analysis and traditional Chinese medicine constitution
Time Frame: 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.
Identification of biomarkers by next-generation sequencing analysis in nasopharyngeal cancer patients.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The quality of life as assessed by the score of questionnaire of European Organisation for Research and Treatment of Cancer C30
Time Frame: 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.
The quality of life for cancer patients as assessed by the score of cancer-specific questionnaire, "European Organisation for Research and Treatment of Cancer (EORTC C30)", which is cancer-specific core questionnaire for use in various cancers with 30 in Functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale, also several single-item symptom measures etc), with range from 1 (Not at all) to 4 (Very much), and from 1 (Very poor) to 7 (Excellent), scoring from 0 to 100. For functional and global quality of life scales, higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.
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.
The quality of life as assessed by the score of questionnaire of European Organisation for Research and Treatment of Cancer H&N35
Time Frame: 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.
The quality of life as assessed by the score of a head & neck cancer-specific questionnaire, "European Organisation for Research and Treatment of Cancer Head and Neck Module (EORTC H&N35)", with 35 items to evaluate symptoms encountered by patients with head and neck cancer in 18 domains, including in 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality) and 11 single items (eg, Opening mouth, Sticky saliva, Dry mouth, etc), with range from 1 (Not at all) to 4 (Very much), and from 1 (Very poor) to 7 (Excellent). EORTC H&N35)have standardized scores ranging from 0 to 100, with higher scores indicating a greater degree of symptoms.
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.
Survival rate
Time Frame: throughout the study, an average of 2 year
Survival after treatment
throughout the study, an average of 2 year
Disease recurrence
Time Frame: throughout the study, an average of 2 year
Disease recurrence after treatment
throughout the study, an average of 2 year
Next-generation sequencing
Time Frame: pre-treatment and after 16 weeks of treatment
The comparison of next-generation sequencing of human gene analysis after treatment
pre-treatment and after 16 weeks of treatment
Immune repertoire
Time Frame: pre-treatment and after 16 weeks of treatment
The comparison of IgG, IgA and T cell receptor immune repertoire after treatment
pre-treatment and after 16 weeks of treatment
Microbiota
Time Frame: pre-treatment and after 16 weeks of treatment
The comparison of gut microbiota after treatment
pre-treatment and after 16 weeks of treatment
Tongue diagnosis
Time Frame: pre-treatment and after 16 weeks of treatment
The comparison of Tongue diagnosis after treatment
pre-treatment and after 16 weeks of treatment
Constitution in Chinese Medicine Questionnaire (CCMQ)
Time Frame: 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.
The Chinese medicine constitution as assessed by the score of Constitution in Chinese Medicine Questionnaire, consists of 60 items in 9 types of Chinese medicine constitution, gentleness, Qi-deficiency, Yang-deficiency, Yin-deficiency, phlegm-dampness, dampness-heat, blood-stasis, Qi-stagnation, and special diathesis, with scaling range from 1(None) to 5(Always). The score would be transform to adjusted scores as｛[ (Total - the number of items)/( the number of items×4)]×100｝with range from 0-100. A higher score indicates that the subject may be more likely to have the specific constitution.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Study Chair: Hen-Hong Chang, Ph.D., China Medical University, China
  • Principal Investigator: Han-Kuei Wu, Ph.D., China Medical University, China
  • Principal Investigator: Kun San Chao, M.D., China Medical University, China
  • Principal Investigator: Eric Y. Chuang, Ph.D., National Taiwan University
  • Principal Investigator: Ming-Hsui Tsai, M.D., China Medical University, China
  • Principal Investigator: Yu-Chuen Huang, Ph.D., China Medical University, China
  • Principal Investigator: Chia-Hao Chang, M.M.S., China Medical University, China
  • Principal Investigator: Yao-Ching Wang, M.M.S., China Medical University, China
  • Principal Investigator: Chun-Hung Hua, M.D., China Medical University, China
  • Principal Investigator: Shih-Neng Yang, M.D., China Medical University, China
  • Principal Investigator: Ying-Chun Lin, M.D., China Medical University, China
  • Principal Investigator: Ti-Hao Wang, M.D., China Medical University, China
  • Principal Investigator: Ching Yun Hsieh, M.D., China Medical University, China
  • Principal Investigator: Ming-Yu Lien, M.D., China Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2018

Primary Completion (Anticipated)

July 31, 2020

Study Completion (Anticipated)

July 31, 2020

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

July 30, 2018

Last Update Submitted That Met QC Criteria

July 26, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH106-REC1-068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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