NCT03578575

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

July 26, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

July 30, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

May 16, 2018

Last Update Submit

July 26, 2018

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinomaConcurrent chemo-radiotherapy

Outcome Measures

Primary Outcomes (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.

    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)

  • The quality of life as assessed by the score of questionnaire of European Organisation for Research and Treatment of Cancer C30

    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

    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

    throughout the study, an average of 2 year

  • Disease recurrence

    throughout the study, an average of 2 year

  • Next-generation sequencing

    pre-treatment and after 16 weeks of treatment

  • +4 more secondary outcomes

Study Arms (2)

Danggui Buxue Tang group

EXPERIMENTAL

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

Drug: Danggui Buxue Tang

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Danggui Buxue TangDRUG

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

Danggui Buxue Tang group
PlaceboDRUG

Placebo is a very low dose Danggui Buxue Tang powder.

Placebo group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41158262DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

danggui buxue decoction

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Hen-Hong Chang, Ph.D.

    China Medical University, China

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hen-Hong Chang, Ph.D.

CONTACT

886-4-22053366tcmchh55@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 120 subjects are divided into experimental group and control group (placebo).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2018

First Posted

July 6, 2018

Study Start

July 26, 2018

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

July 30, 2018

Record last verified: 2018-07

Locations

TW(1)