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J Clin Oncol. 2014 May 20;32(15):1571-7. doi: 10.1200/JCO.2013.53.2630. Epub 2014 Apr 14.

Doxepin rinse versus placebo in the treatment of acute oral mucositis pain in patients receiving head and neck radiotherapy with or without chemotherapy: a phase III, randomized, double-blind trial (NCCTG-N09C6 [Alliance]).

Author information

1
James L. Leenstra, St Vincent Regional Cancer Center, Green Bay, WI; Robert C. Miller, Rui Qin, James A. Martenson, Paul J. Novotny, Robert L. Foote, and Charles L. Loprinzi, Mayo Clinic, Rochester; Kenneth J. Dornfeld, Essentia Health Cancer Center, Duluth, MN; James D. Bearden, Palmetto Hematology Oncology, Spartanburg, SC; Dev R. Puri, Mercy Cancer Center, Des Moines, IA; Philip J. Stella, St Joseph Mercy Cancer Care Center, Ann Arbor, MI; Miroslaw A. Mazurczak, Sandford Health Cancer Center, Sioux Falls, SD; and Marie D. Klish, Hope Cancer Center, Longmont, CO.
2
James L. Leenstra, St Vincent Regional Cancer Center, Green Bay, WI; Robert C. Miller, Rui Qin, James A. Martenson, Paul J. Novotny, Robert L. Foote, and Charles L. Loprinzi, Mayo Clinic, Rochester; Kenneth J. Dornfeld, Essentia Health Cancer Center, Duluth, MN; James D. Bearden, Palmetto Hematology Oncology, Spartanburg, SC; Dev R. Puri, Mercy Cancer Center, Des Moines, IA; Philip J. Stella, St Joseph Mercy Cancer Care Center, Ann Arbor, MI; Miroslaw A. Mazurczak, Sandford Health Cancer Center, Sioux Falls, SD; and Marie D. Klish, Hope Cancer Center, Longmont, CO. miller.robert@mayo.edu.

Abstract

PURPOSE:

Painful oral mucositis (OM) is a significant toxicity during radiotherapy for head and neck cancers. The aim of this randomized, double-blind, placebo-controlled trial was to test the efficacy of doxepin hydrochloride in the reduction of radiotherapy-induced OM pain.

PATIENTS AND METHODS:

In all, 155 patients were randomly allocated to a doxepin oral rinse or a placebo for the treatment of radiotherapy-related OM pain. Patients received a single dose of doxepin or placebo on day 1 and then crossed over to receive the opposite agent on a subsequent day. Pain questionnaires were administered at baseline and at 5, 15, 30, 60, 120, and 240 minutes. Patients were then given the option to continue doxepin. The primary end point was pain reduction as measured by the area under the curve (AUC) of the pain scale using data from day 1.

RESULTS:

Primary end point analysis revealed that the AUC for mouth and throat pain reduction was greater for doxepin (-9.1) than for placebo (-4.7; P < .001). Crossover analysis of patients completing both phases confirmed that patients experienced greater mouth and throat pain reduction with doxepin (intrapatient changes of 4.1 for doxepin-placebo arm and -2.8 for placebo-doxepin arm; P < .001). Doxepin was associated with more stinging or burning, unpleasant taste, and greater drowsiness than the placebo rinse. More patients receiving doxepin expressed a desire to continue treatment than did patients with placebo after completion of each of the randomized phases of the study.

CONCLUSION:

A doxepin rinse diminishes OM pain. Further studies are warranted to determine its role in the management of OM.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01156142.

PMID:
24733799
PMCID:
PMC4026580
DOI:
10.1200/JCO.2013.53.2630
[Indexed for MEDLINE]
Free PMC Article

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