Phase 3
Completed N=230
Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
Acute Oral Mucositis Pain
Source: ClinicalTrials.gov NCT02229539 ↗
Enrolled (actual)
230
Serious AEs
3.6%
Results posted
Apr 2017
Primary outcomePrimary: Mean Area Under the Curve (AUC) of Total Pain Reduction — 11.6; 11.7; 8.7 units on a scale*time scale — p=0.02
◆ Published Evidence
Established
89citations · ~13 / year
Effect of Doxepin Mouthwash or Diphenhydramine-Lidocaine-Antacid Mouthwash vs Placebo on Radiotherapy-Related Oral Mucositis Pain: The Alliance A221304 Randomized Clinical Trial.
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.
Linked Publications
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Effect of Doxepin Mouthwash or Diphenhydramine-Lidocaine-Antacid Mouthwash vs Placebo on Radiotherapy-Related Oral Mucositis Pain: The Alliance A221304 Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Area Under the Curve (AUC) of Total Pain Reduction |
11.6; 11.7; 8.7 | 0.02 sig |
| SECONDARY Area Under the Curve (AUC) of Total Unpleasant Taste of the Oral Rinse |
3.5; 2.0; 0.8 | — |
| SECONDARY Area Under the Curve (AUC) of Total Stinging or Burning From the Oral Rinse |
5.3; 0.8; 0.5 | — |
| SECONDARY Area Under the Curve (AUC) of Total Drowsiness |
0; -1.8; 0 | — |
| SECONDARY The Incidence of Using Alternative Analgesics |
10; 7; 14; 13; 14; 21 | — |
| SECONDARY Patient Preference for Continued Therapy With Oral Rinse After Initial Test Rinse Phase |
45; 46; 38 | — |
| SECONDARY Frequency of Study Rinse Used in the Continuation Phase |
33; 37; 30; 2; 0; 1 | — |
| SECONDARY Median Mouth Pain Score in the Continuation Phase |
6.0; 5.5; 5.0; 5.0; 5.5; 5.0 | — |
| SECONDARY The Incidence of Using Alternative Analgesics in the Continuation Phase |
22; 20; 21; 12; 15; 10 | — |
Eligibility Criteria
- Documentation of Disease: Histologic documentation of malignancy currently undergoing a course of RT (with or without chemotherapy) including the oral cavity and/or oropharyngeal area to a dose of at least 4500 cGy using more than 5 fractions (i.e., stereotactic body radiation therapy [SBRT] is not allowed).
- Physical exam demonstrating evidence of radiotherapy-related mucositis in the visible oral cavity and/or oropharynx consistent with mucous membrane toxicity greater than 0 using the Acute Radiation Morbidity Scoring Criteria.
- At least 4 (out of 10) patient-reported oral pain related to oral mucositis secondary to RT for which the patient seeks relief, as measured on the Oral Pain Assessment.
Note: The pain score must be at least 4 at the time that the patient starts the first dose of study medication. The patient may be enrolled to the study if s/he, at times, has a pain score of at least 4, so long as initiation of study treatment begins when the pain score is at least 4.
- Ability to complete questionnaire(s) by themselves or with assistance.
- No known allergy to diphenhydramine, lidocaine, antacid (aluminum hydroxide, magnesium hydroxide, and simethicone), doxepin, tricyclic antidepressants, or any known component of the drug formulation in the testing arms.
- No use of any anti-arrhythmic medication (except for beta-blockers) including lidocaine, linezolid, ipratropium, or medications with high anti-cholinergic potency (including neostigmine, a tricyclic antidepressant or a monoamine oxidase inhibitor) within 2 weeks prior to registration.
- No current diagnosed untreated or unresolved oral candidiasis or oral HSV infection.
- No history of untreated narrow angle glaucoma within 6 weeks prior to registration.
- No untreated urinary retention within 6 weeks prior to registration.
- No current use of glutamine or sucralfate powders at the time of registration (no washout required).
- No cryotherapy for prophylactic mucosal protection within 6 weeks prior to registration.
- Not pregnant, because patients eligible for this study will be receiving radiotherapy, which has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 28 days prior to registration is required.
- Age ≥ 18 years
- ECOG Performance Status 0, 1, or 2
Data sourced from ClinicalTrials.gov (NCT02229539) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.