For patients with head and neck cancer who are undergoing radiotherapy, using a nasal mask to deliver humidified air to the mouth and throat region while they were sleeping appears to have reduced symptoms, and significantly shortened their hospital stay.
The results come from the RadioHUM study, a phase 3 trial conducted in 210 patients reported here at a plenary session during the 2014 Multidisciplinary Head and Neck Cancer Symposium. This study has just been published in the March 1 issue of theInternational Journal of Radiation Oncology * Biology * Physics.
Radiotherapy for head and neck cancer often results in mucositis, with patients developing painful inflammation and ulceration of the mouth and throat that can negatively affect their quality of life, explained principal investigator Andrew McCann, MBcHB, a radiation oncologist at Auckland City Hospital in New Zealand.
The trial investigated daily humidification of the mouth and throat region (using the Fisher & Paykel Healthcare MR880 humidifier) starting on the first day of radiotherapy. The humidified air is delivered through the nose via a mask-type of apparatus, which patients wear while they are sleeping or sitting. “This provides a greater level of humidification than has previously been available,” he said.“The rationale for humidification is based on the fact that moisturizing wounds generally helps them to heal faster,” he said during a press briefing.
In this trial, patients used this device for a mean of 3.6 hours per day (range, 1 – 14 hours).
However, the authors note that only 43 patients (42%) in the humidification group met a defined benchmark for humidifier compliance. Only these patients contributed to the per protocol analysis, so although the results were in the direction of less symptom severity, most of the time points did not reach significance. Nevertheless, they say there were “efficacy signals consistent with a role for humidification in reducing symptom burden from mucositis,” and this included the patient reports in a self-assessment questionnaire.
However, several of the results did reach statistical significance.
Patients who used the humidifier had a significantly shorter hospital stay (mean of 2.3 vs 4.1 days in the control group; P = .017), and fewer of them required hospital readmission (0.31 vs 0.55; P = .013).
This effect of reducing hospitalization may make this approach cost-effective, the authors comment.
In addition, significantly fewer patients who had used a humidifier needed an eating tube, and a nutritional status assessment at 20 weeks after the radiotherapy showed that significantly more patients in this group had returned to near-normal eating patterns.
“The results are encouraging, particularly given the signal favoring humidification was seen across clinician-reported outcomes, patient-reported outcomes, and independent data such as hospitalizations,” the authors note.
“This is important,” Dr. McCann suggested, “because when you see signals across these different types of outcomes, there is some independent corroboration there.”
Patients didn’t use the humidifier as much as we had hoped, Dr. McCann commented. Some of the issues with compliance are similar to those seen with the use of continuous positive airway pressure machines in patients with sleep apnea, he said. “Our next step is to work to increase the proportion of patients who use the humidifier effectively,” he added.