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New treatment option for Radiation-induced Oral Mucositis
Official title Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis
ClinicalTrials.gov ID: NCT06939582
What this study is testing
What is Hydroxychloroquine Sulfate Tablets?
Hydroxychloroquine Sulfate Tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for radiation-induced oral mucositis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluate the safety, tolerance and efficacy of hydroxychloroquine sulfate tablets the prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients pathologically diagnosed with non-metastatic head and neck malignant tumors
- Aged 18-80 years
- Eastern Cooperative Oncology Group performance status of ≤2
- Planning to receive definitive RT or postoperative adjuvant RT
- Normal liver, kidney and bone marrow function
You likely can't join if
- Those who are known to be allergic to 4-aminoquinoline compounds or have more serious allergic constitution
- Had a history of head and neck radiotherapy
- Patients with non head and neck parts in the radiotherapy area
- Poor oral hygiene or severe periodontitis
- Suffering from severe kidney disease, severe cardiovascular disease, myasthenia gravis, Parkinson's disease or epilepsy
- Recently taking or taking diuretics or other drugs known to interact with hydroxychloroquine sulfate tablets
See the full eligibility criteria
- Patients pathologically diagnosed with non-metastatic head and neck malignant tumors
- Aged 18-80 years
- Eastern Cooperative Oncology Group performance status of ≤2
- Planning to receive definitive RT or postoperative adjuvant RT
- Normal liver, kidney and bone marrow function
- Sign informed consent
- Those who are known to be allergic to 4-aminoquinoline compounds or have more serious allergic constitution
- Had a history of head and neck radiotherapy
- Patients with non head and neck parts in the radiotherapy area
- Poor oral hygiene or severe periodontitis
- Suffering from severe kidney disease, severe cardiovascular disease, myasthenia gravis, Parkinson's disease or epilepsy
- Recently taking or taking diuretics or other drugs known to interact with hydroxychloroquine sulfate tablets
- Retinopathy
- Other patients (combined with any serious other diseases) who the investigator believes are not suitable for participation in this study
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.