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]).

Autor:	Leenstra JL; 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 RC; 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., Qin R; 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., Martenson JA; 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., Dornfeld KJ; 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., Bearden JD; 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., Puri DR; 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., Stella PJ; 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., Mazurczak MA; 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., Klish MD; 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., Novotny PJ; 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., Foote RL; 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., Loprinzi CL; 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.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2014 May 20; Vol. 32 (15), pp. 1571-7. Date of Electronic Publication: 2014 Apr 14.
DOI:	10.1200/JCO.2013.53.2630
Abstrakt:	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. (© 2014 by American Society of Clinical Oncology.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu