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Nasopharyngeal CarcinomaPhase 2NCT03578575

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

A Phase 2 study testing Danggui Buxue Tang in people with Nasopharyngeal Carcinoma, run by China Medical University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
Danggui Buxue Tang
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteTaiwan
Study dates
26 Jul 2018to 31 Jul 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with pathological diagnosis of nasopharyngeal carcinoma stage II ~ IVa (AJCC eighth edition) preparing to receive concurrent chemoradiotherapy

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hen-Hong Chang, Ph.D. contact

886-4-22053366 ext. 3001

tcmchh55@gmail.com

Taiwan1 site, 1 recruiting

  • China Medical University Hospital

    Taichung, 404

    Hen-Hong Chang, M.D., Ph.D., +886-4-22053366 ext. 3501, tcmchh55@gmail.com

    Ching-Mao Chang, M.D., 886

    Recruiting

Other trials in Taiwan

About this study

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.

Read the 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".

Being tested
Danggui Buxue Tang, Placebo
Keywords
Nasopharyngeal carcinoma, Concurrent chemo-radiotherapy
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Danggui Buxue TangDrug

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

  • PlaceboDrug

    Placebo is a very low dose Danggui Buxue Tang powder.

Study groups in NCT03578575
Study groupRoleWhat they receive
Danggui Buxue Tang groupExperimentalUse Danggui Buxue Tang 5g/time, 3 times a day, for 12 weeks.
Receives: Drug: Danggui Buxue Tang
Placebo groupPlacebo comparatorUse Placebo 5g/time, 3 times a day, for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The correlation between next-generation sequencing analysis and traditional Chinese medicine constitution

    Identification of biomarkers by next-generation sequencing analysis in nasopharyngeal cancer patients.

    Measured: 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 outcomes (9)

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

  3. Survival rate

    Survival after treatment

    Measured: throughout the study, an average of 2 year

  4. Disease recurrence

    Disease recurrence after treatment

    Measured: throughout the study, an average of 2 year

  5. Next-generation sequencing

    The comparison of next-generation sequencing of human gene analysis after treatment

    Measured: pre-treatment and after 16 weeks of treatment

  6. Immune repertoire

    The comparison of IgG, IgA and T cell receptor immune repertoire after treatment

    Measured: pre-treatment and after 16 weeks of treatment

  7. Microbiota

    The comparison of gut microbiota after treatment

    Measured: pre-treatment and after 16 weeks of treatment

  8. Tongue diagnosis

    The comparison of Tongue diagnosis after treatment

    Measured: pre-treatment and after 16 weeks of treatment

  9. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2018
  2. Study start26 Jul 2018
  3. Primary completion31 Jul 2020 (estimated)
  4. Study completion31 Jul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
120 subjects are divided into experimental group and control group (placebo).
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03578575
Sponsor's protocol ID
CMUH106-REC1-068
Status last verified
Jul 2018
First submitted
16 May 2018
Last updated
30 Jul 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hsieh HY, Yang SN, Lien MY, Wang YC, Chang CH, Wu HK, Hsu YC, Hsieh CY, Huang YC, Chang HH. Combination of Danggui Buxue Tang and concurrent chemoradiotherapy improves treatment outcomes by strengthening B cell immunity in patients with nasopharyngeal carcinoma-a double-blind, randomized trial. Transl Cancer Res. 2025 Sep 30;14(9):5199-5210. doi: 10.21037/tcr-2025-406. Epub 2025 Sep 26.

    PubMed 41158262

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Danggui Buxue Tang in people with Nasopharyngeal Carcinoma, run by China Medical University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hen-Hong Chang, Ph.D. (886-4-22053366 ext. 3001, tcmchh55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03578575, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.

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