Phase 3
N=155
Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy
Head and Neck Cancer · Mucositis · Oral Complications of Radiation Therapy · Pain
Bottom Line
View on ClinicalTrials.gov: NCT01156142 ↗Enrolled (actual)
155
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Total Pain Reduction (Mouth and Throat) — -9.1; -4.7 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- doxepin hydrochloride (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Pain Reduction (Mouth and Throat) |
-9.1; -4.7 | <0.001 sig |
| SECONDARY Total Taste of the Oral Rinse |
7.7; 5.1 | 0.0018 sig |
| SECONDARY Total Stinging or Burning From the Oral Rinse |
9.6; 4.0 | 0.001 sig |
| SECONDARY Total Drowsiness Increase |
-0.7; -2.4 | 0.0297 sig |
| SECONDARY Incidence of Using Alternative Analgesics Between 2 and 4 Hours After the Initial Mouthwash |
8.8; 2.9; 16.9; 14.5 | 0.1392 |
| SECONDARY Patient Preference for Continuing Therapy With Oral Doxepin Hydrochloride |
77.3; 51.5 | 0.0018 sig |
Summary
RATIONALE: Doxepin hydrochloride may be an effective treatment for oral mucositis pain in patients undergoing radiation therapy with or without chemotherapy.
PURPOSE: This randomized phase III trial is studying doxepin hydrochloride to see how well it works compared to placebo in treating oral mucositis pain in patients with head and neck cancer undergoing radiation therapy with or without chemotherapy.
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years of age
- Histologic proof of malignancy currently undergoing a course of RT (with or without chemotherapy) to a dose of ≥ 5000 cGy using 1.60 to 2.20 Gy per fraction. Note: At least one third of the oral cavity mucosa must be included in the radiation therapy fields.
- ≥ 4 oral pain felt to be related to mucositis for which the patient wants relief as measured by the Numeric Measure of Oral Pain. Note: An oral exam confirming the presence of mucositis should be performed by the enrolling clinician in addition to patient feedback.
- Ability to complete questionnaire(s) independently or with assistance
- ECOG Performance Status 0, 1 or 2.
- Provide informed written consent.
- Willingness to return to enrolling institution for follow-up.
Exclusion Criteria
- Known allergy to doxepin, tricyclic antidepressants, or any known component of the drug formulation
- Use of a tricyclic antidepressant or monoamine oxidase inhibitor within the 2 weeks prior to registration
- Current untreated or unresolved oral candidiasis or oral HSV infection
- Current untreated narrow angle glaucoma
- Current untreated urinary retention ≤ 6 weeks prior to registration
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Any of the following because this study involves a study agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
Data sourced from ClinicalTrials.gov (NCT01156142). 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.