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

NCT01156142 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2017-08-09

Study results available
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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.

Conditions

Interventions

DRUG

doxepin hydrochloride

Oral rinse

OTHER

placebo

Oral rinse

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Robert C. Miller, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-05-31
Completion
2015-03-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01156142 on ClinicalTrials.gov