Herbal mouthwash may stop radiation mouth sores before they start
NCT ID NCT07543978
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a modified herbal mouthwash can prevent painful mouth sores caused by radiation therapy in people with head and neck cancer. About 156 participants will use either the herbal mouthwash or a placebo during their radiation treatment. The goal is to see if the mouthwash reduces the number of people who develop sores within the first two weeks of treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 156 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 to 70 years (inclusive) at the time of screening. 2. Histologically confirmed squamous cell carcinoma of the nasopharynx, oral cavity, or oropharynx. 3. Planned to receive radiotherapy. 4. No prior history of radiotherapy to the head and neck region. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Adequate major organ function as defined by the following criteria (within 14 days prior to enrollment, without transfusion support): Hemoglobin (Hb) ≥90 g/L Absolute neutrophil count (ANC)≥1.5×10⁹/L Platelet count (PLT) ≥80×10⁹/L Total bilirubin (BIL) \< 1.25×upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5×ULN Serum creatinine (Cr)≤ULN, or calculated creatinine clearance (Cockcroft-Gault formula) \> 50 mL/min 7. Signed written informed consent prior to any study-related procedures. 8. Judged by the investigator to be able to comply with the study protocol. 9. Negative pregnancy test (for women of childbearing potential) at screening. 10. Willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. Pre-existing oral mucositis prior to the start of radiotherapy. 2. Prior radiotherapy to the head and neck region. 3. Major surgery within 3 weeks prior to enrollment. 4. Uncontrolled cardiac conditions or symptoms, including but not limited to: New York Heart Association (NYHA) class II or higher heart failure Unstable angina pectoris Myocardial infarction within 1 year prior to enrollment Clinically significant supraventricular or ventricular arrhythmia requiring intervention 5. Use of topical (oral) or systemic corticosteroids within 1 week prior to enrollment. 6. Active infection requiring systemic therapy. 7. Known history of substance abuse, alcohol abuse, or drug addiction. 8. Pregnancy or breastfeeding. 9. Any other condition that, in the investigator's judgment, may interfere with the participant's ability to complete the study or compromise the collection of study data, including but not limited to serious concurrent illness (including psychiatric disorders) requiring concomitant treatment, severely abnormal laboratory values, or unfavorable family or social circumstances.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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More trials for these conditions
Other studies related to the condition(s) this trial covers.
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