- Determine whether doxepin hydrochloride mouth rinse, compared to placebo, is effective in reducing oral mucositis-related pain in patients with head and neck cancer undergoing radiotherapy with or without chemotherapy.
- Assess the adverse event profile of these regimens, using a patient-reported questionnaire at 5, 15, 30, 60, 120, and 240 minutes, in these patients.
- Compare the incidence of using alternative analgesics 4 hours before and in between these regimens in these patients.
- Assess patient preference for continuing therapy with oral doxepin hydrochloride after initial test rinse or after optional cross-over phase.
- Assess pain reduction and other adverse event profile in patients who cross-over to the optional blinded phase using the same patient-reported questionnaire.
- Assess pain reduction and other adverse event profile in patients who continue to receive optional oral doxepin hydrochloride.
OUTLINE: This is a multicenter study. Patients are stratified according to gender, concurrent radiosensitizing chemotherapy (yes vs no), and age (< 60 years vs ≥ 60 years). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxepin hydrochloride oral rinse (swish, gargle, and spit)* over 1 minute on day 1. Patients may crossover to arm II on day 2.
- Arm II: Patients receive placebo oral rinse (swish, gargle, and spit)* over 1 minute on day 1. Patients may crossover to arm I on day 2.
NOTE: * Patients are instructed to avoid taking medications for mucositis pain 60 minutes before and after study medication.
After completing study therapy, patients have the option to receive doxepin hydrochloride oral rinse every 4 hours as needed during radiotherapy.
Patients complete questionnaires at baseline, and at 5, 15, 30, 60, 120, and 240 minutes after study medication. Patients who choose to continue doxepin hydrochloride oral rinse also complete weekly questionnaires.
- Histologically confirmed head and neck cancer meeting the following criteria:
- Undergoing radiotherapy with or without chemotherapy
- At least 1/3 of the oral cavity mucosa must be included in the radiotherapy field
- Oral pain related to mucositis of ≥ grade 4 and for which the patient wants relief as measured by patient response to a pain scale question rating (0 to 10)
- ECOG performance status 0-2
- No known allergy to doxepin hydrochloride, tricyclic antidepressants, or any known component of the drug formulation
- No untreated or unresolved oral candidiasis or oral herpes simplex virus infection
- No untreated narrow-angle glaucoma
- No untreated urinary retention in the past 6 weeks
- No co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study, or interfere significantly with proper assessment of safety and toxicity of the prescribed regimens
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 2 weeks since prior tricyclic antidepressant or monoamine oxidase inhibitor
- No viscous lidocaine, 'magic mouthwash', benzocaine, diphenhydramine, or other medicated oral rinse within 4 hours before or after the study medication
- Normal saline or baking soda rinse allowed
Last updated: 02/28/2013
NCT ID: NCT01156142