title: A feasibility and efficacy trial of a hand-held humidification device in patients undergoing radiotherapy for head and neck cancer.
abstract: This study aimed to evaluate the effects of warm-mist humidification during and after head and neck radiation therapy (HN RT) on quality of life (QOL), as measured by the M. D. Anderson Symptom Inventory-Head and Neck (MDASI-HN) HN score. A secondary aim was to compare QOL among compliers (≥60% of protocol-recommended usage) versus non-compliers.
  
  
  
  Twenty patients self-administered a hand-held, self-sterilizing humidification device for a recommended time of at least 15 min twice daily for 12 weeks. Patients completed the MDASI-HN instrument at RT start, after 6 weeks, and after 12 weeks. Compliance was reported weekly.
  
  
  
  The average HN score at baseline was 1.7 (SD = 1.8) and increased to 6.0 (SD = 1.6) after 6 weeks; this increase was much higher than anticipated and the primary endpoint could not be reached. However, compliers had an average of nearly two less HN symptoms (-1.8, 95% CI -4 to 0.2; p = 0.08) than non-compliers at 6 weeks and fewer symptoms at 12 weeks as well (-0.9, 95% CI -2.9 to 1.2; p = 0.39). The most common terms patients used to describe humidification were "helpful" and "soothing."
  
  
  
  Compliance with humidification during RT was associated with fewer reported HN symptoms and a strong trend to better QOL. Improvements were seen from compliance with occasional required use of a portable, inexpensive device. Our findings support continued efforts to reduce barriers to humidification, as an intervention that should be considered for standard HN RT clinical practice.
authors.affiliation: Department of Radiation Oncology, University of California San Francisco, 1600 Divisadero Street, Suite H-1031, San Francisco, CA, 94143-1708, USA.
authors.forename: Priyanka
authors.initials: P
authors.lastname: Ghosh
authors.affiliation: Department of Preventive and Restorative Dental Sciences & Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.
authors.forename: Ann A
authors.initials: AA
authors.lastname: Lazar
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, University of California San Francisco, San Francisco, CA, USA.
authors.forename: William R
authors.initials: WR
authors.lastname: Ryan
authors.affiliation: Department of Radiation Oncology, University of California San Francisco, 1600 Divisadero Street, Suite H-1031, San Francisco, CA, 94143-1708, USA. yoms@radonc.ucsf.edu.|Department of Otolaryngology-Head and Neck Surgery, University of California San Francisco, San Francisco, CA, USA. yoms@radonc.ucsf.edu.
authors.forename: Sue S
authors.initials: SS
authors.lastname: Yom
mesh_terms: D005240:Feasibility Studies; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D000068998:Humidifiers / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011788:Quality of Life / Q000523:psychology*
keywords: Head and neck radiation therapy; Humidification; Quality of life