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(s): Leenstra JL(1), Miller RC(2), Qin R(1), Martenson JA(1), Dornfeld KJ(1), Bearden
JD(1), Puri DR(1), Stella PJ(1), Mazurczak MA(1), Klish MD(1), Novotny PJ(1),
Foote RL(1), Loprinzi CL(1).
Affiliation(s): 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.
Publication date & source: 2014, J Clin Oncol. , 32(15):1571-7
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.
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