Local Injection Methylene Blue Combined With Radiation in HNSCC Patients (NCT07435415) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Local Injection Methylene Blue Combined With Radiation in HNSCC Patients
Taiwan10 participantsStarted 2025-08-01
Plain-language 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. 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. . 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.
. . Age ≧20 years old; and life expectancy of at least 12 weeks.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Any unexpected severe adverse event resulting from the combination treatment.
Timeframe: "through study completion, an average of 1 year"
. . 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.
Exclusion criteria
. . 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.