M A Criswell1, C K Sinha. 1. Otolaryngology Service, Department of Surgery, Walter Reed Army Medical Center, Washington, DC 20307-5001, USA.
Abstract
OBJECTIVES: To investigate the role of hyperthermic, supersaturated humidification in the treatment of radiation-induced xerostomia. STUDY DESIGN: A randomized, controlled, crossover pilot study of patients with symptomatic xerostomia following radiotherapy for head and neck cancer. Patients compared a standard bedside humidifier with a new device delivering hyperthermic, supersaturated humidification through a nasal cannula. METHODS: The patients were randomized to a 2-week course of standard, cool air bedside humidification or to hyperthermic, supersaturated humidification through a nasal cannula (Vapotherm Inc., Annapolis, MD). After a 1-week washout period, patients were crossed over to the opposite device for another 2 weeks. The patients underwent physical examination initially and after each trial period using an objective xerostomia scale, and then completed a questionnaire quantifying their symptoms. Patients additionally rated their symptoms at home, twice daily, using a visual analogue scale. RESULTS: Using the Oral Assessment Guide, lip scores went from 1.67 initially to 1.67 after control and 1.67 after Vapotherm. Tongue scores were 1.67, 1.5, and 1.83, respectively. Saliva scores were 1.67, 1.5, and 1.5, respectively. Mucous membranes scores were 1.5, 1.67, and 1.5, respectively. The physical examination scores at these four sites were not significantly different between control and Vapotherm (P =.78,.78,.72, and.37, respectively). The patient symptom questionnaire and visual analogue scores also revealed no significant difference between the two devices. CONCLUSION: The Vapotherm MT-3000 device appears to provide minimal or no additional relief from radiation xerostomia over standard bedside humidifiers. Further investigation may be warranted with newer models of the device and with disorders of mucociliary clearance.
RCT Entities:
OBJECTIVES: To investigate the role of hyperthermic, supersaturated humidification in the treatment of radiation-induced xerostomia. STUDY DESIGN: A randomized, controlled, crossover pilot study of patients with symptomatic xerostomia following radiotherapy for head and neck cancer. Patients compared a standard bedside humidifier with a new device delivering hyperthermic, supersaturated humidification through a nasal cannula. METHODS: The patients were randomized to a 2-week course of standard, cool air bedside humidification or to hyperthermic, supersaturated humidification through a nasal cannula (Vapotherm Inc., Annapolis, MD). After a 1-week washout period, patients were crossed over to the opposite device for another 2 weeks. The patients underwent physical examination initially and after each trial period using an objective xerostomia scale, and then completed a questionnaire quantifying their symptoms. Patients additionally rated their symptoms at home, twice daily, using a visual analogue scale. RESULTS: Using the Oral Assessment Guide, lip scores went from 1.67 initially to 1.67 after control and 1.67 after Vapotherm. Tongue scores were 1.67, 1.5, and 1.83, respectively. Saliva scores were 1.67, 1.5, and 1.5, respectively. Mucous membranes scores were 1.5, 1.67, and 1.5, respectively. The physical examination scores at these four sites were not significantly different between control and Vapotherm (P =.78,.78,.72, and.37, respectively). The patient symptom questionnaire and visual analogue scores also revealed no significant difference between the two devices. CONCLUSION: The Vapotherm MT-3000 device appears to provide minimal or no additional relief from radiation xerostomia over standard bedside humidifiers. Further investigation may be warranted with newer models of the device and with disorders of mucociliary clearance.