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New treatment option for Swallowing-induced Pain
Official title Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT06017895
What this study is testing
What is doxepin solution?
doxepin solution is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for swallowing-induced pain.
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
- The goal of this clinical trial is to explore the effectiveness and adverse reactions of doxepin solution spray for alleviation of stubborn breakthrough pain induced by swallowing in patients receiving radiotherapy for nasopharyngeal carcinoma.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provide informed written consent.
- Age ≥ 18 years.
- Histologically confirmed as nasopharyngeal carcinoma, and currently undergoing radical radiotherapy or chemoradiotherapy.
- Physical examination demonstrating the presence of radiation-induced mucositis in the oral cavity and/or oropharynx.
- At least 4 (out of 10) patient-reported swallowing-induced pain as measured by the numeric rating scale of pain.
You likely can't join if
- Known allergy to doxepin, tricyclic antidepressants, or any known component of the drug formulation.
- Use of a tricyclic antidepressant or monoamine oxidase inhibitor within 14 days prior to registration.
- Current untreated or unhealed oral candidiasis or oral herpes simplex virus infection.
- Untreated narrow angle glaucoma within 6 weeks prior to registration.
- Untreated urinary retention within 6 weeks prior to registration.
- Administration of cryotherapy to prevent oral mucositis within 6 weeks prior to registration.
See the full eligibility criteria
- Provide informed written consent.
- Age ≥ 18 years.
- Histologically confirmed as nasopharyngeal carcinoma, and currently undergoing radical radiotherapy or chemoradiotherapy.
- Physical examination demonstrating the presence of radiation-induced mucositis in the oral cavity and/or oropharynx.
- At least 4 (out of 10) patient-reported swallowing-induced pain as measured by the numeric rating scale of pain.
- Being able to complete the questionnaires independently or with assistance.
- ECOG Performance Status 0, 1 or 2.
- Known allergy to doxepin, tricyclic antidepressants, or any known component of the drug formulation.
- Use of a tricyclic antidepressant or monoamine oxidase inhibitor within 14 days prior to registration.
- Current untreated or unhealed oral candidiasis or oral herpes simplex virus infection.
- Untreated narrow angle glaucoma within 6 weeks prior to registration.
- Untreated urinary retention within 6 weeks prior to registration.
- Administration of cryotherapy to prevent oral mucositis within 6 weeks prior to registration.
- Current serious heart disease or a recent history of myocardial infarction.
- Current untreated or unresolved conditions like epilepsy, hyperthyroidism, hepatic dysfunction, delirium, and neutropenia.
- Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.