Patients who received daily humidification of the mouth and throat region beginning from day one of radiation therapy treatment spent nearly 50 percent fewer days in the hospital to manage their side effects, according to research presented today at the 2014 Multidisciplinary Head and Neck Cancer Symposium.
The study was conducted by the Trans Tasman Radiation Oncology Group and evaluated 210 head and neck cancer patients in New Zealand and Australia from June 2007 through June 2011. Patients in this Phase III trial were randomized to institutional standard of care (control arm) or humidification (HUM) using the Fisher & Paykel Healthcare MR880 humidifier. The humidified air is delivered through the nose via a plastic interface (mask-type apparatus) that can be worn by patients while sleeping or while sitting during the day.
Patients began HUM on day one of radiation therapy and continued until the ulceration their mouth and throat had resolved. On average, HUM patients spent 57 percent as many days in the hospital to manage side effects (control = 4.1 days vs. HUM = 2.3 days). The return of eating patterns to close to normal was also significantly higher at three months after radiotherapy in the group using humidifiers. (Nutritional Mode score at 20 weeks, a clinician-reported assessment of nutritional status, control = 4.8 vs. HUM = 5.23.)
Only 43 patients (42 percent of the patients in the HUM arm) met the defined benchmark of HUM compliance and were able to contribute to the per protocol (PP) analysis; the mean average use of humidification for these patients was 3.6 hours per day (range of 0-14 hours/day). In patients who met the HUM compliance benchmark, the area under the curve for CTCAE version 3.0 functional mucositis score (a clinician assessment of mucositis symptom burden for patients) was reduced (control = 8.63 vs. HUM PP = 6.74). The proportion of compliant HUM patients who never required a feeding tube was also increased (control = 0.73 vs. HUM PP = 0.85). There was also a trend for patients to report a reduction in symptom burden when using humidification but only in those patients compliant in using the humidifier.