Macann, A., Fua, T., Milross, C.G., Porceddu, S.V., Penniment, M., Wratten, C., ... Hockey, H.U. (2014). Phase 3 trial of domiciliary humidification to mitigate acute mucosal toxicity during radiation therapy for head-and-neck cancer: First report of Trans Tasman Radiation Oncology Group (TROG) 07.03 RadioHUM study. International Journal of Radiation Oncology, Biology, Physics, 88(3), 572–579. 

To evaluate domicile-based humidification on mucositis symptoms associated with radiation in patients with head and neck cancer

Inpatients were randomized 1:1. The control group (n = 100) received the institutional standard of care for managing mucositis (as defined by each institution), and the intervention group (n = 103) received the standard of care plus domicile-based humidification with the Fisher & Paykel Healthcare MR880 humidifier. The humidifier was set at 37°C and 100% relative humidity. 44 mg of vaporized water per liter of air was delivered via nasal prongs. Sensors were used for continuous feedback and to optimize delivery and prevent condensation. The rate of flow was selected to promote some leakage of moisture into the oral cavity and began at 25 L per minute. Flow was increased 30 L per minute if tolerated by the patient. Humidification began on the first day of radiation therapy with continuous use at night and additional use during the day. The intervention continued for 12 weeks. Patients who had a mucositis score ≥ 2 at week 12 continued the intervention until his or her score was < 2 or until week 16, whichever occurred first. The electronically recorded compliance was set with four hours of daily humidifier use as the benchmark. Data were recorded weekly until week 12 for all patients and weekly until week 16, or until mucositis scores were < 2, for some patients. Additional data were collected at weeks 12 and 20.

• N = 203            
• AGE = Patients were all ages 
• MALES: 164 (80.8%), FEMALES: 39 (19.2%)
• KEY DISEASE CHARACTERISTICS: Head and neck cancer

• SITE: Multi-site 
• SETTING TYPE: Outpatient  
• LOCATION: Eleven participating institutions across Australia and New Zealand

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care, palliative care

Randomized, controlled trial

• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI, CTCAE) version 3.0
• McMaster University Head and Neck Radiotherapy Questionnaire (HNRQ) 
• MD Anderson Symptom Inventory Head and Neck Module 
• Fiberoptic endoscopic examination

High, medium, and low humidifier compliance rates were reported in 23, 20, and 60 patients, respectively. Per protocol (PP) patients were those in the medium and high compliance groups. The difference in compliance was significant between institutions (range = 0.11–0.74, mean = 0.37, p = 0.004). The mean number of hours the intervention device was used was 3.6 hours (range = 0–14 hours). Differences in the institutions' ​area under the curve (AUC) for mucositis scores ≥ 2 were significant (range = 6.87–11.87, p = 0.008). There was no difference in the AUC in CTCAE scores. There was a difference between groups in PP functional mucositis scores ≥ 2 (p = 0.009) and ≥ 3 (p = 0.006).

Humidification can decrease the severity of mucositis and decrease the time to healing of ulcerated mucositis. Unfortunately, there was a low rate of compliance with the home-based humidification intervention. Patients in the study cited the following reasons for disliking the intervention: dislike of high-flow rate, heat, plastic nasal interface odor or bore size, and noise during the night. The study also showed that patients who reported the highest satisfaction with the humidifier were those who had the most symptom relief from its use.

• Risk of bias (no blinding)
• Other limitations/explanation: High rate of noncompliance with intervention

Patients who were compliant with the intervention saw a reduction in the severity of mucositis and faster healing of oral ulcers. The majority of patients enrolled, however, reported low compliance with the intervention for a variety of reasons. The use of a humidifier at home may appeal to some patients. Nurses can play an important role in assessing if patients are ready to make a life change that includes an intervention such as this one. Patients who were compliant with the intervention reported more symptom relief than patients who were not compliant.