title: 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.
abstract: OBJECTIVE
  To assess the impact of domicile-based humidification on symptom burden during radiation therapy (RT) for head-and-neck (H&N) cancer.
  
  
  METHODS
  From June 2007 through June 2011, 210 patients with H&N cancer receiving RT were randomized to either a control arm or to receive humidification using the Fisher & Paykel Healthcare MR880 humidifier. Humidification commenced on day 1 of RT and continued until Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, clinical mucositis (CMuc) grade ≤1 occurred. Forty-three patients (42%) met a defined benchmark for humidification compliance and contributed to per protocol (PP) analysis. Acute toxicities, hospitalizations, and feeding tube events were recorded prospectively. The McMaster University Head and Neck Radiotherapy Questionnaire (HNRQ) was used for patient-reported outcomes. The primary endpoint was area under the curve (AUC) for CMuc grade ≥2.
  
  
  RESULTS
  There were no significant differences in AUC for CMuc ≥2 between the 2 arms. Humidification patients had significantly fewer days in hospital (P=.017). In compliant PP patients, the AUC for CTCAE functional mucositis score (FMuc) ≥2 was significantly reduced (P=.009), and the proportion who never required a feeding tube was significantly greater (P=.04). HNRQ PP analysis estimates also in the direction favoring humidification with less symptom severity, although differences at most time points did not reach significance.
  
  
  CONCLUSIONS
  TROG 07.03 has provided efficacy signals consistent with a role for humidification in reducing symptom burden from mucositis, but the influence of humidification compliance on the results moderates recommendations regarding its practical utility.
authors: Department of Radiation Oncology, Auckland City Hospital, Auckland, New Zealand. Electronic address: amacann@adhb.govt.nz.
authors: Andrew
authors: A
authors: Macann
authors: Department of Radiation Oncology, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia.
authors: Tsien
authors: T
authors: Fua
authors: Department of Radiation Oncology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
authors: Chris G
authors: CG
authors: Milross
authors: Oncology Services, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.
authors: Sandro V
authors: SV
authors: Porceddu
authors: Radiation Oncology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
authors: Michael
authors: M
authors: Penniment
authors: Radiation Oncology, Calvary Mater Newcastle, Waratah, New South Wales, Australia.
authors: Chris
authors: C
authors: Wratten
authors: Department of Radiation Oncology, Auckland City Hospital, Auckland, New Zealand.
authors: Hedley
authors: H
authors: Krawitz
authors: Department of Radiation Oncology, Radiation Oncology Mater Centre, South Brisbane, Queensland, Australia.
authors: Michael
authors: M
authors: Poulsen
authors: Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.
authors: Colin I
authors: CI
authors: Tang
authors: Department of Otorhinolaryngology, Middlemore Hospital, Otahuhu, Auckland, New Zealand.
authors: Randall P
authors: RP
authors: Morton
authors: Department of Oral Health, Auckland City Hospital, Auckland, New Zealand.
authors: K David
authors: KD
authors: Hay
authors: Department of Otorhinolaryngology, Auckland City Hospital, Auckland, New Zealand.
authors: Vicki
authors: V
authors: Thomson
authors: Psycho-oncology Cooperative Research Group, Univerity of Sydney, Sydney, New South Wales, Australia.
authors: Melanie L
authors: ML
authors: Bell
authors: Psycho-oncology Cooperative Research Group, Univerity of Sydney, Sydney, New South Wales, Australia.
authors: Madeleine T
authors: MT
authors: King
authors: Adult Oncology Research Centre, Auckland City Hospital, Auckland, New Zealand.
authors: Carol L
authors: CL
authors: Fraser-Browne
authors: Biometrics Matters Ltd, Hamilton, New Zealand.
authors: Hans-Ulrich P
authors: HU
authors: Hockey
mesh_terms: D019540:Area Under Curve; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D006813:Humidity; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000528:radiation effects*; D052016:Mucositis / Q000209:etiology / Q000628:therapy*; D010349:Patient Compliance; D010465:Perception; D011832:Radiation Injuries / Q000209:etiology / Q000628:therapy*