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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Danggui Buxue Tang is an extracted powder of traditional Chinese medicine formula.
Placebo is a very low dose Danggui Buxue Tang powder.
China Medical University Hospital
Taichung, Taiwan
RECRUITINGThe correlation between next-generation sequencing analysis and traditional Chinese medicine constitution
Identification of biomarkers by next-generation sequencing analysis in nasopharyngeal cancer patients.
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.
The quality of life as assessed by the score of questionnaire of European Organisation for Research and Treatment of Cancer C30
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.
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 questionnaire of European Organisation for Research and Treatment of Cancer H&N35
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.
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.
Survival rate
Survival after treatment
Time frame: throughout the study, an average of 2 year
Disease recurrence
Disease recurrence after treatment
Time frame: throughout the study, an average of 2 year
Next-generation sequencing
The comparison of next-generation sequencing of human gene analysis after treatment
Time frame: pre-treatment and after 16 weeks of treatment
Immune repertoire
The comparison of IgG, IgA and T cell receptor immune repertoire after treatment
Time frame: pre-treatment and after 16 weeks of treatment
Microbiota
The comparison of gut microbiota after treatment
Time frame: pre-treatment and after 16 weeks of treatment
Tongue diagnosis
The comparison of Tongue diagnosis after treatment
Time frame: pre-treatment and after 16 weeks of treatment
Constitution in Chinese Medicine Questionnaire (CCMQ)
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.
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.
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