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.
Subject(s)
Acute Pain/drug therapy , Analgesics/administration & dosage , Chemoradiotherapy/adverse effects , Cranial Irradiation/adverse effects , Doxepin/administration & dosage , Facial Pain/drug therapy , Head and Neck Neoplasms/radiotherapy , Stomatitis/drug therapy , Acute Pain/chemically induced , Acute Pain/diagnosis , Adult , Aged , Aged, 80 and over , Analgesics/adverse effects , Area Under Curve , Cross-Over Studies , Double-Blind Method , Doxepin/adverse effects , Facial Pain/chemically induced , Facial Pain/diagnosis , Female , Head and Neck Neoplasms/drug therapy , Humans , Male , Middle Aged , Mouthwashes , Pain Measurement , Predictive Value of Tests , Stomatitis/chemically induced , Stomatitis/diagnosis , Surveys and Questionnaires , Time Factors , Treatment Outcome , United StatesABSTRACT
This article reviews the basic principles of radiobiology and the application thereof to the treatment of metastatic spine tumors. The most important concepts of dose fractionation and the concept of biologically effective dose as well as spinal cord tolerance to single and multiple doses of radiotherapy are emphasized. Basic principles of treatment planning for radiotherapy and radiosurgery are outlined.
Subject(s)
Radiosurgery , Spinal Cord/radiation effects , Spinal Neoplasms/radiotherapy , Spinal Neoplasms/surgery , Humans , Radiation Tolerance , Radiotherapy Dosage , Radiotherapy, Computer-Assisted , Relative Biological Effectiveness , Spinal Neoplasms/secondaryABSTRACT
Although promising, many questions remain regarding spinal IMRT. The challenge of patient immobilization must be surmounted before a radiation facility can safely offer spinal IMRT. At many institutions, the increased expense and time requirements from physicists, therapists, and physicians preclude the routine use of IMRT for spinal lesions. Finally, there are no randomized data comparing the safety or efficacy of IMRTwith more conventional means of spinal radiation. Nonetheless, IMRT is one of the most important recent technologic advancements in radiation therapy. For complex treatment problems, such as spinal tumors, in which the surrounding organs at risk traditionally place significant constraints on the prescription dose, IMRT has great potential to provide the ideal solution.
