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: | James L. Leenstra, James D. Bearden, Marie D. Klish, Dev R. Puri, Philip J. Stella, Paul J. Novotny, James A. Martenson, Robert C. Miller, Robert L. Foote, Charles L. Loprinzi, Kenneth J. Dornfeld, Miroslaw Mazurczak, Rui Qin |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male Cancer Research Time Factors Mouthwashes Placebo law.invention Double-Blind Method Randomized controlled trial Facial Pain Predictive Value of Tests law Surveys and Questionnaires Mucositis Humans Medicine Aged Pain Measurement Aged 80 and over Analgesics Stomatitis Cross-Over Studies business.industry Area under the curve Chemoradiotherapy ORIGINAL REPORTS Pain scale Middle Aged medicine.disease Doxepin Acute Pain Crossover study United States Treatment Outcome Oncology Head and Neck Neoplasms Area Under Curve Anesthesia Female Cranial Irradiation business Doxepin Hydrochloride medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 32:1571-1577 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2013.53.2630 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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