Clinical trial NCT01156142
Conditions: Head and Neck Cancer Mucositis Oral Complications of Radiation Therapy Pain
Keywords: oral complications of radiation therapy mucositis pain stage I squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the hypopharynx squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx squamous cell carcinoma of the larynx verrucous carcinoma of the larynx recurrent adenoid cystic carcinoma of the oral cavity recurrent mucoepidermoid carcinoma of the oral cavity recurrent verrucous carcinoma of the oral cavity adenoid cystic carcinoma of the oral cavity mucoepidermoid carcinoma of the oral cavity verrucous carcinoma of the oral cavity squamous cell carcinoma of the lip and oral cavity recurrent basal cell carcinoma of the lip recurrent squamous cell carcinoma of the lip and oral cavity basal cell carcinoma of the lip metastatic squamous neck cancer with occult primary squamous cell carcinoma recurrent metastatic squamous neck cancer with occult primary untreated metastatic squamous neck cancer with occult primary recurrent lymphoepithelioma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx lymphoepithelioma of the nasopharynx squamous cell carcinoma of the nasopharynx recurrent lymphoepithelioma of the oropharynx recurrent squamous cell carcinoma of the oropharynx lymphoepithelioma of the oropharynx squamous cell carcinoma of the oropharynx recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity recurrent inverted papilloma of the paranasal sinus and nasal cavity recurrent midline lethal granuloma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity esthesioneuroblastoma of the paranasal sinus and nasal cavity inverted papilloma of the paranasal sinus and nasal cavity midline lethal granuloma of the paranasal sinus and nasal cavity squamous cell carcinoma of the paranasal sinus and nasal cavity high-grade salivary gland mucoepidermoid carcinoma low-grade salivary gland mucoepidermoid carcinoma recurrent salivary gland cancer salivary gland acinic cell tumor salivary gland adenocarcinoma salivary gland adenoid cystic carcinoma salivary gland anaplastic carcinoma salivary gland malignant mixed cell type tumor salivary gland poorly differentiated carcinoma salivary gland squamous cell carcinoma salivary gland cancer tongue cancer
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2010-12-01; Completion date: 2015-03-02
Enrollment: 155 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief 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.

Detailed description:
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. The primary and secondary objectives are detailed below.

Primary Objective:

Determine whether doxepin oral rinse is effective in reducing OM-related pain in patients undergoing RT to the oral cavity, as measured by a patient-reported questionnaire at 5,15, 30, 60, 120 and 240 minutes

Secondary Objectives:

1. Assess the adverse event profile of doxepin rinse using a patient-reported questionnaire at 5, 15, 30, 60, 120 and 240 minutes for domains of unpleasant taste, burning or stinging discomfort, and drowsiness.
2. Compare the incidence of using alternative analgesics before 4 hours, between the doxepin oral rinse and placebo arms.
3. Assess patient preference for continued therapy with oral rinse after initial test rinse or after the cross-over phase.

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.

Arms: arm 1: 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 2: Patients receive placebo oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
Interventions: intervention 1: doxepin hydrochloride intervention 2: placebo
Intervention descriptions: intervention 1: Oral rinse intervention 2: Oral rinse

Protocol documents: