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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-26

Study Completion Date

2020-07-31

Brief Summary

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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.

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Detailed Description

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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".

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

120 subjects are divided into experimental group and control group (placebo).

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Danggui Buxue Tang group

Use Danggui Buxue Tang 5g/time, 3 times a day, for 12 weeks.

Group Type EXPERIMENTAL

Danggui Buxue Tang

Intervention Type DRUG

Danggui Buxue Tang is an extracted powder of traditional Chinese medicine formula.

Placebo group

Use Placebo 5g/time, 3 times a day, for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo is a very low dose Danggui Buxue Tang powder.

Interventions

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Danggui Buxue Tang

Danggui Buxue Tang is an extracted powder of traditional Chinese medicine formula.

Intervention Type DRUG

Placebo

Placebo is a very low dose Danggui Buxue Tang powder.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR