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

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ClinicalTrials.gov Identifier: NCT03578575
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Tracking Information
First Submitted Date  ICMJE May 16, 2018
First Posted Date  ICMJE July 6, 2018
Last Update Posted Date July 30, 2018
Actual Study Start Date  ICMJE July 26, 2018
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03578575 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2018)
  • 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.
  • 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.
  • Survival rate [ Time Frame: throughout the study, an average of 2 year ]
    Survival after treatment
  • Disease recurrence [ Time Frame: throughout the study, an average of 2 year ]
    Disease recurrence after treatment
  • 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
  • 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
  • Microbiota [ Time Frame: pre-treatment and after 16 weeks of treatment ]
    The comparison of gut microbiota after treatment
  • Tongue diagnosis [ Time Frame: pre-treatment and after 16 weeks of treatment ]
    The comparison of Tongue diagnosis after 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Investigate the Molecular Mechanism of Traditional Chinese Medicine Constitution Using Next-generation Sequencing in Nasopharyngeal Carcinoma
Official Title  ICMJE To Investigate the Molecular Mechanism of Traditional Chinese Medicine Constitution Using Next-generation Sequencing in Nasopharyngeal Carcinoma
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".

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
120 subjects are divided into experimental group and control group (placebo).
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Danggui Buxue Tang group
    Use Danggui Buxue Tang 5g/time, 3 times a day, for 12 weeks.
    Intervention: Drug: Danggui Buxue Tang
  • Placebo Comparator: Placebo group
    Use Placebo 5g/time, 3 times a day, for 12 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hen-Hong Chang, Ph.D. 886-4-22053366 ext 3001 tcmchh55@gmail.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03578575
Other Study ID Numbers  ICMJE CMUH106-REC1-068
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party China Medical University Hospital
Study Sponsor  ICMJE China Medical University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account China Medical University Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP