Mouth spray could tame agonizing swallowing pain during cancer radiation
NCT ID NCT06017895
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This clinical trial tests whether a doxepin solution spray can relieve severe breakthrough pain when swallowing, a common side effect of radiation therapy for nasopharyngeal carcinoma. About 178 patients will be randomly assigned to receive either the doxepin spray or a placebo spray. Researchers will measure pain reduction and any drowsiness at several time points after use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- doxepin solution
- What this could lead to
- If effective, this spray could offer quick relief from severe swallowing pain during radiotherapy, improving quality of life for patients with nasopharyngeal carcinoma.
- What could go wrong
- This is a relatively small, early-stage trial. The spray may cause drowsiness or other side effects, and its pain-relieving effect may not be strong enough to be clinically useful.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 178 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Aug 2026
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 years and older
- 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. Provide informed written consent. 2. Age ≥ 18 years. 3. Histologically confirmed as nasopharyngeal carcinoma, and currently undergoing radical radiotherapy or chemoradiotherapy. 4. Physical examination demonstrating the presence of radiation-induced mucositis in the oral cavity and/or oropharynx. 5. At least 4 (out of 10) patient-reported swallowing-induced pain as measured by the numeric rating scale of pain. 6. Being able to complete the questionnaires independently or with assistance. 7. ECOG Performance Status 0, 1 or 2. Exclusion Criteria: 1. Known allergy to doxepin, tricyclic antidepressants, or any known component of the drug formulation. 2. Use of a tricyclic antidepressant or monoamine oxidase inhibitor within 14 days prior to registration. 3. Current untreated or unhealed oral candidiasis or oral herpes simplex virus infection. 4. Untreated narrow angle glaucoma within 6 weeks prior to registration. 5. Untreated urinary retention within 6 weeks prior to registration. 6. Administration of cryotherapy to prevent oral mucositis within 6 weeks prior to registration. 7. Current serious heart disease or a recent history of myocardial infarction. 8. Current untreated or unresolved conditions like epilepsy, hyperthyroidism, hepatic dysfunction, delirium, and neutropenia. 9. Pregnant or lactating women.
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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 places running it
1 site. The list below names each one and where it is.
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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
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Southern medical university
RECRUITINGGuangzhou, Guangdong, 510515, China