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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03578575
• Other study ID #: CMUH106-REC1-068
• Status: Recruiting
• Phase: Phase 2
• Start date: July 26, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: July 2018
• Source: China Medical University Hospital
• Contact: Hen-Hong Chang, Ph.D.
• Phone: 886-4-22053366
• Email: tcmchh55[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Danggui Buxue Tang
Danggui Buxue Tang is an extracted powder of traditional Chinese medicine formula.
• Placebo
Placebo is a very low dose Danggui Buxue Tang powder.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation between next-generation sequencing analysis and traditional Chinese medicine constitution	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	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.	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.
Secondary	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.	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.
Secondary	Survival rate	Survival after treatment	throughout the study, an average of 2 year
Secondary	Disease recurrence	Disease recurrence after treatment	throughout the study, an average of 2 year
Secondary	Next-generation sequencing	The comparison of next-generation sequencing of human gene analysis after treatment	pre-treatment and after 16 weeks of treatment
Secondary	Immune repertoire	The comparison of IgG, IgA and T cell receptor immune repertoire after treatment	pre-treatment and after 16 weeks of treatment
Secondary	Microbiota	The comparison of gut microbiota after treatment	pre-treatment and after 16 weeks of treatment
Secondary	Tongue diagnosis	The comparison of Tongue diagnosis after treatment	pre-treatment and after 16 weeks of treatment
Secondary	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.	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.