Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy
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.
Head and Neck Cancer
Oral Complications of Radiation Therapy
Drug: doxepin hydrochloride
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||A Randomized Double-Blind Study of Doxepin Rinse Versus Placebo in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy|
- Total pain reduction (mouth and throat) [ Time Frame: Baseline and Day 1 ]
- Total taste of the oral rinse [ Time Frame: Up to 9 days ]
- Total stinging or burning from the oral rinse [ Time Frame: Up to 9 days ]
- Total drowsiness increase [ Time Frame: Up to 9 days ]
- Incidence of using alternative analgesics 4 hours before and in between study medications [ Time Frame: Up to 9 days ]
- Patient preference for continuing therapy with oral doxepin hydrochloride [ Time Frame: Up to 9 days ]
- Pain reduction and other adverse event profile in the blinded cross-over phase [ Time Frame: Up to 9 days ]
- Long-term outcome of doxepin hydrochloride oral rinse for patient continued therapy [ Time Frame: Up to 9 days ]
|Study Start Date:||December 2010|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: 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.
Drug: doxepin hydrochloride
Placebo Comparator: 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.
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.
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
- 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.
- Compare the incidence of using alternative analgesics before 4 hours, between the doxepin oral rinse and placebo arms.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156142
Show 120 Study Locations
|Study Chair:||Robert C. Miller, MD||Mayo Clinic|