Clinical trial · Interventional
To Investigate the Molecular Mechanism of Traditional Chinese Medicine Constitution Using Next-generation Sequencing in Nasopharyngeal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Danggui Buxue Tang | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Danggui Buxue Tang group
- description
- Use Danggui Buxue Tang 5g/time, 3 times a day, for 12 weeks.
- interventionNames
- Drug: Danggui Buxue Tang
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- Use Placebo 5g/time, 3 times a day, for 12 weeks.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- The correlation between next-generation sequencing analysis and traditional Chinese medicine constitution
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHsieh 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 41158262