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NCT07435415
Local Injection Methylene Blue Combined With Radiation in HNSCC Patients
EARLY_PHASE1 trial testing Methylene Blue (50 mg/10ml) in Head and Neck Cancer in 10 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2026
Quick facts
| Lead sponsor | China Medical University Hospital |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 1 August 2025 |
| Primary completion | 31 December 2026 |
| Estimated completion | 30 June 2027 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Methylene Blue (50 mg/10ml) — full drug profile →
Conditions studied
- Head and Neck Cancer — all drugs for Head and Neck Cancer →
- Local Recurrent Tumor — all drugs for Local Recurrent Tumor →
Sponsor
China Medical University Hospital
Who can join
20 and older, any sex, with Head and Neck Cancer or Local Recurrent Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to investigate the effectiveness of Methylene Blue (MB) as a radiosensitizer in treating head and neck squamous cell carcinoma (HNSCC) that has recurred locally and is resistant to radiation therapy. It will also assess the safety of Methylene Blue. The main questions it aims to answer are: Does Methylene Blue improve the outcomes for patients with recurrent HNSCC receiving radiation therapy? What side effects do participants experience while receiving Methylene Blue? Participants will: Receive weekly injections of Methylene Blue or placebo into the tumor over six weeks. Undergo six weeks of concurrent radiation therapy. Be monitored regularly for treatment effects and document any side effects experienced during the trial. This single-center clinical trial intends to recruit 10 eligible patients diagnosed with locoregional recurrence of HNSCC that is resistant to previous radiotherapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07435415
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other China Medical University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07435415 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by China Medical University Hospital
- Last refreshed: 27 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07435415.
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