Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy

• Total pain reduction (mouth and throat) [ Designated as safety issue: No ]
  

• Total taste of the oral rinse as measured by the numerical analogue scale of taste of the oral rinse in the questionnaires [ Designated as safety issue: No ]
  
• Total stinging or burning from the oral rinse [ Designated as safety issue: No ]
  
• Total drowsiness increase [ Designated as safety issue: No ]
  
• Incidence of using alternative analgesics 4 hours before and in between study medications [ Designated as safety issue: No ]
  
• Patient preference for continuing therapy with oral doxepin hydrochloride [ Designated as safety issue: No ]
  
• Pain reduction and other adverse event profile in the optional blinded cross-over phase [ Designated as safety issue: Yes ]
  
• Long-term outcome of doxepin hydrochloride oral rinse as measured by weekly questionnaire responses [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• 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.

Secondary

• 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.

Tertiary

• 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.