Swallowing-induced PainNCT06017895
Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma
A study testing doxepin solution in people with Swallowing-induced Pain, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Swallowing-induced Pain
- What is being tested?
- doxepin solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Southern medical university
Guangzhou, Guangdong, 510515
Jian Guan, MD, 86+13632102247, guanjian5461@163.com
Jian Guan, MD
About this study
Official title: Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patient Receiving Radiotherapy for Nasopharyngeal Carcinoma: A Multicenter, Randomized, Controlled, Double-Blind Clinical Trial
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.
Read the detailed description
Patients with nasopharyngeal carcinoma receiving radical radiotherapy or chemoradiotherapy who developed oral mucositis and had a swallowing-induced pain score ≥ 4 were recruited and randomly assigned 1:1 to the experimental group and the control group.
Patients in the experimental group received a doxepin solution spray to the posterior pharyngeal wall 10 minutes before eating. At least 12 hours later, when the swallowing-induced pain score ≥4, a placebo spray was administered to the posterior pharyngeal wall 10 minutes before eating.
Patients in the control group received a placebo spray to the posterior pharyngeal wall 10 minutes before eating. At least 12 hours later, when the swallowing-induced pain score ≥4, a doxepin solution spray was administered to the posterior pharyngeal wall 10 minutes before eating.
The swallowing-induced pain and incidence of adverse events were assessed at 10 minutes, 20 minutes, 30 minutes, and 1 hour after medication using a patient-reported questionnaire, and safety evaluation was conducted 1 day after treatment.
- Conditions
- Swallowing-induced Pain
- Being tested
- doxepin solution, Placebo
- Keywords
- Nasopharyngeal carcinoma, Oral mucositis, Radiotherapy, Swallowing-induced pain, Doxepin
- Medical subject headings
- Nasopharyngeal Carcinoma, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxepin solutionDrug
2.0 mL doxepin solution (5mg/mL) sprayed to the posterior pharyngeal wall
PlaceboOther
2.0 mL placebo sprayed to the posterior pharyngeal wall
| Study group | Role | What they receive |
|---|---|---|
| doxepin solution | Experimental | Patients received a doxepin solution spray to the posterior pharyngeal wall 10 minutes before eating. At least 12 hours later, when the swallowing-induced pain score ≥4, a placebo spray was administered to the posterior pharyngeal wall 10 minutes before eating. Receives: Drug: doxepin solution |
| placebo | Placebo comparator | Patients received a placebo spray to the posterior pharyngeal wall 10 minutes before eating. At least 12 hours later, when the swallowing-induced pain score ≥4, a doxepin solution spray was administered to the posterior pharyngeal wall 10 minutes before eating. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Redution of swallowing-induced pain
The redution of swallowing-induced pain was measured by the numerical analogue scale of 0 to 10, with 0=no pain and 10=worst pain in the questionnaires taken at baseline, and 10, 20, 30, 60 minutes after assigned administration.
Measured: Baseline, and 10, 20, 30, 60 minutes after administration
Secondary outcomes (6)
Total Drowsiness Increase
The total drowsiness increase was measured by the numerical analogue scale of 0 to 10, with 0=no drowsiness and 10=extreme drowsiness in the questionnaires taken at baseline, and 10, 20, 30, 60 minutes after assigned administration.
Measured: Baseline, and 10, 20, 30, 60 minutes after administration
Total Taste of the Agent
The total taste of the agent was measured by the numerical analogue scale of 0 to 10, with 0=acceptable and 10=terrible in the questionnaires taken at 10, 20, 30 and 60 minutes after assigned administration.
Measured: 10, 20, 30 and 60 minutes after administration
Total Stinging or Burning From the Agent
The stinging or burning of the oral cavity/oropharynx was measured by the numerical analogue scale of 0 to 10, with 0=no stinging or burning and 10=worst stinging or burning in the questionnaires taken at 10, 20, 30 and 60 minutes after assigned administration.
Measured: 10, 20, 30 and 60 minutes after administration
Difficulty in Swallowing Different Food
The difficulty in swallowing liquids, pureed food and solid food was measured respectively by the numerical analogue scale of 0 to 10, with 0=not at all and 10=very much in the questionnaires taken at 10, 20, 30 and 60 minutes after assigned administration.
Measured: Baseline, and 10, 20, 30, 60 minutes after administration
Patient Preference for Continuing Therapy With the Agent
Patients were asked if they would like to continue treatment with that particular agent at 60 minutes after assigned administration.
Measured: 60 minutes after administration
Adverse Event Profiles
Adverse events were assessed and record using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.
Measured: up to one day after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start31 Oct 2023
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing-induced PainStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Guan, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017895
- Sponsor's protocol ID
- NFEC-2023-351
- Status last verified
- Jun 2026
- First submitted
- 24 Aug 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patient Receiving Radiotherapy for Nasopharyngeal Carcinoma: A Multicenter, Randomized, Controlled, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06017895
- Acronym / sponsor ID
- NFEC-2023-351
- Conditions
- Swallowing-induced Pain
- Keywords
- Nasopharyngeal carcinoma, Oral mucositis, Radiotherapy, Swallowing-induced pain, Doxepin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with nasopharyngeal carcinoma receiving radical radiotherapy or chemoradiotherapy who developed oral mucositis and had a swallowing-induced pain score ≥ 4 were recruited and randomly assigned 1:1 to the experimental group and the control group.
Patients in the experimental group received a doxepin solution spray to the posterior pharyngeal wall 10 minutes before eating. At least 12 hours later, when the swallowing-induced pain score ≥4, a placebo spray was administered to the posterior pharyngeal wall 10 minutes before eating.
Patients in the control group received a placebo spray to the posterior pharyngeal wall 10 minutes before eating. At least 12 hours later, when the swallowing-induced pain score ≥4, a doxepin solution spray was administered to the posterior pharyngeal wall 10 minutes before eating.
The swallowing-induced pain and incidence of adverse events were assessed at 10 minutes, 20 minutes, 30 minutes, and 1 hour after medication using a patient-reported questionnaire, and safety evaluation was conducted 1 day after treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| doxepin solution | Experimental | Drug: doxepin solutionPatients received a doxepin solution spray to the posterior pharyngeal wall 10 minutes before eating. At least 12 hours later, when the swallowing-induced pain score ≥4, a placebo spray was administered to the posterior pharyngeal wall 10 minutes before eating. |
| placebo | Placebo comparator | Other: PlaceboPatients received a placebo spray to the posterior pharyngeal wall 10 minutes before eating. At least 12 hours later, when the swallowing-induced pain score ≥4, a doxepin solution spray was administered to the posterior pharyngeal wall 10 minutes before eating. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doxepin solution2.0 mL doxepin solution (5mg/mL) sprayed to the posterior pharyngeal wall | Drug | doxepin solution |
| Placebo2.0 mL placebo sprayed to the posterior pharyngeal wall | Other | placebo |
Primary outcome
Redution of swallowing-induced pain
Time frame: Baseline, and 10, 20, 30, 60 minutes after administration
The redution of swallowing-induced pain was measured by the numerical analogue scale of 0 to 10, with 0=no pain and 10=worst pain in the questionnaires taken at baseline, and 10, 20, 30, 60 minutes after assigned administration.
6 secondary outcomes
Total Drowsiness Increase
Time frame: Baseline, and 10, 20, 30, 60 minutes after administration
Total Taste of the Agent
Time frame: 10, 20, 30 and 60 minutes after administration
Total Stinging or Burning From the Agent
Time frame: 10, 20, 30 and 60 minutes after administration
Difficulty in Swallowing Different Food
Time frame: Baseline, and 10, 20, 30, 60 minutes after administration
Patient Preference for Continuing Therapy With the Agent
Time frame: 60 minutes after administration
Adverse Event Profiles
Time frame: up to one day after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Swallowing-induced Pain
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A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis
Radiation-induced Oropharyngeal Mucositis, Swallowing-induced Breakthrough Pain
RecruitingObservational study
A Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Radiation-induced Oropharyngeal Mucositis
Radiation-induced Oropharyngeal Mucositis, Swallowing-induced Breakthrough Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Guan, MD principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing doxepin solution in people with Swallowing-induced Pain, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Guan, MD (+86-13632102247, 51643930@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Redution of swallowing-induced pain (time frame: Baseline, and 10, 20, 30, 60 minutes after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.