Overview

This trial is active, not recruiting.

Conditions head and neck cancer, mucositis, oral complications of radiation therapy, pain
Treatments doxepin hydrochloride, placebo
Phase phase 3
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date December 2010
End date May 2012
Trial size 162 participants
Trial identifier NCT01156142, CDR0000675520, NCCTG-N09C6, NCI-2011-02049, U10CA037404

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Experimental)
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.
doxepin hydrochloride
Oral rinse
(Placebo Comparator)
Patients receive placebo oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
placebo
Oral rinse

Primary Outcomes

Measure
Total pain reduction (mouth and throat)
time frame: Baseline and Day 1

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. ≥ 18 years of age 2. 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. 3. ≥ 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. 4. Ability to complete questionnaire(s) independently or with assistance 5. ECOG Performance Status 0, 1 or 2. 6. Provide informed written consent. 7. Willingness to return to enrolling institution for follow-up. Exclusion Criteria: 1. Known allergy to doxepin, tricyclic antidepressants, or any known component of the drug formulation 2. Use of a tricyclic antidepressant or monoamine oxidase inhibitor within the 2 weeks prior to registration 3. Current untreated or unresolved oral candidiasis or oral HSV infection 4. Current untreated narrow angle glaucoma 5. Current untreated urinary retention ≤ 6 weeks prior to registration 6. 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 7. 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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.