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Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy

NCT02229539 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2025-05-18

Study results available
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Summary

The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.

Conditions

  • Acute Oral Mucositis Pain

Interventions

DRUG

doxepin hydrochloride oral solution

2.5 mL (25 mg) doxepin and 2.5 mL water administered orally

DRUG

DLA (diphenhydramine, lidocaine and antacids) rinse

5.0 mL administered orally

OTHER

Placebo

2.5 mL placebo and 2.5 mL water administered orally

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Robert Miller, MD, MS · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-18
Primary Completion
2016-05-23
Completion
2019-03-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02229539 on ClinicalTrials.gov