Head and Neck CancerEarly Phase 1NCT07435415
Local Injection Methylene Blue Combined With Radiation in HNSCC Patients
A Early Phase 1 study testing Methylene Blue (50 mg/10ml) in people with Head and Neck Cancer and Local Recurrent Tumor, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Head and Neck Cancer, Local Recurrent Tumor
- What is being tested?
- Methylene Blue (50 mg/10ml)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2025to 30 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . Histologically confirmed squamous cell carcinoma of head and neck.
- . Locoregional recurrence.
- . After standard treatment of R/M HNSCC.
- . Measurable disease. Defined as presence of at least one lesion as being ≥10 mm in at least one dimension measured with conventional computed tomography (CT) or ≥10 mm in at least one dimension measured with spiral CT scan or magnetic resonance imaging (MRI).
- . Lesion selection criteria - at least 1 lesion to be injected must be measurable and greater than or equal to 1.5 cm and longest diameter not exceed 10 cm in principle.
- . ECOG performance status ≤2.
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- . Age ≧20 years old; and life expectancy of at least 12 weeks.
- . Prior treatments with radiation therapy for palliative management of non-target lesion metastatic disease is permitted provided that at least 2 weeks have elapsed since the last fraction of radiation therapy, disease progression has been documented and all treatment related adverse events are ≦ grade 1 at the time of registration.
- . Must not have received anticancer therapy used with an antineoplastic intent, including chemotherapy, immunotherapy, biologic, or any investigational therapy within 14 days prior to the first dose of study drug.
- . No history of allergic reactions attributed to methylene blue.
- . Patient consent must be obtained.
- . Negative pregnancy test, Fertile patients must use effective contraception.
Who cannot join
- . Presence of central nervous system (CNS) metastases.
- . The organ function measured within 14 days prior to study entry as defined below: Absolute neutrophil count (ANC) less than 1,000/mm3, or platelets less than 100,000/mm3; serum bilirubin greater than 1.5 times the upper limit of normal range (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases, or greater than 5 times the ULN in the presence of liver metastases; creatinine clearance ≤40 ml/min.
- . Concomitant illness including uncontrolled infection or other active, uncontrolled disease such as congestive heart failure, angina pectoris, respiratory insufficiency, and arrhythmia.
- . Documented hypersensitivity to methylene blue compound or compounds of similar chemical or biologic composition.
- . Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Pilot Study of Tumor Local Injection Methylene Blue Combined With Radiation for Radiation Resistance Local Recurrent Head and Neck Cancer Squamous Cell Carcinoma
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?
Read more
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.
- Conditions
- Head and Neck Cancer, Local Recurrent Tumor
- Being tested
- Methylene Blue (50 mg/10ml)
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene Blue (50 mg/10ml)Drug
- Methylene blue (50mg/10mL): Volume: 2 mL, 5 mL, 8 mL and 10mL are used for intratumoral injections in different lesion sizes. Frequency: weekly
- Radiation dose: 50-60 Gy for target lesions
| Study group | Role | What they receive |
|---|---|---|
| Methylene blue intratumoral injection combined with radiation | Experimental | Not described Receives: Drug: Methylene Blue (50 mg/10ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any unexpected severe adverse event resulting from the combination treatment.
The investigators specify that the key feasibility objectives for our study would be considered successful if the following are met: 80% of patients received methylene blue experience no unpredicted harm during the treatment of methylene blue. The definition of unpredicted harm includes death within one month after last dose of methylene blue administration, or unpredicted ≧ grade 3 AE during methylene blue administration. The severity of adverse events was assessed using CTCAE v5.0.
Measured: "through study completion, an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, Taiwan
- Responsible party
- Principal investigator, Ching Yun Hsieh, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435415
- Sponsor's protocol ID
- CMUH114-REC1-108
- Status last verified
- Oct 2025
- First submitted
- 22 Nov 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pilot Study of Tumor Local Injection Methylene Blue Combined With Radiation for Radiation Resistance Local Recurrent Head and Neck Cancer Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07435415
- Acronym / sponsor ID
- CMUH114-REC1-108
- Conditions
- Head and Neck Cancer, Local Recurrent Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- China Medical University, Taiwan
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylene blue intratumoral injection combined with radiation | Experimental | Drug: Methylene Blue (50 mg/10ml) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- . Histologically confirmed squamous cell carcinoma of head and neck.
- . Locoregional recurrence.
- . After standard treatment of R/M HNSCC.
- . Measurable disease. Defined as presence of at least one lesion as being ≥10 mm in at least one dimension measured with conventional computed tomography (CT) or ≥10 mm in at least one dimension measured with spiral CT scan or magnetic resonance imaging (MRI).
- . Lesion selection criteria - at least 1 lesion to be injected must be measurable and greater than or equal to 1.5 cm and longest diameter not exceed 10 cm in principle.
Key exclusion criteria (5 listed)
- . Presence of central nervous system (CNS) metastases.
- . The organ function measured within 14 days prior to study entry as defined below: Absolute neutrophil count (ANC) less than 1,000/mm3, or platelets less than 100,000/mm3; serum bilirubin greater than 1.5 times the upper limit of normal range (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases, or greater than 5 times the ULN in the presence of liver metastases; creatinine clearance ≤40 ml/min.
- . Concomitant illness including uncontrolled infection or other active, uncontrolled disease such as congestive heart failure, angina pectoris, respiratory insufficiency, and arrhythmia.
- . Documented hypersensitivity to methylene blue compound or compounds of similar chemical or biologic composition.
- . Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene Blue (50 mg/10ml)1. Methylene blue (50mg/10mL): Volume: 2 mL, 5 mL, 8 mL and 10mL are used for intratumoral injections in different lesion sizes. Frequency: weekly 2. Radiation dose: 50-60 Gy for target lesions | Drug | Methylene blue intratumoral injection combined with radiation |
Primary outcome
Any unexpected severe adverse event resulting from the combination treatment.
Time frame: "through study completion, an average of 1 year"
The investigators specify that the key feasibility objectives for our study would be considered successful if the following are met: 80% of patients received methylene blue experience no unpredicted harm during the treatment of methylene blue. The definition of unpredicted harm includes death within one month after last dose of methylene blue administration, or unpredicted ≧ grade 3 AE during methylene blue administration. The severity of adverse events was assessed using CTCAE v5.0.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Methylene Blue (50 mg/10ml) in people with Head and Neck Cancer and Local Recurrent Tumor, 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 12 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any unexpected severe adverse event resulting from the combination treatment. (time frame: "through study completion, an average of 1 year"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.