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
- Department of Radiation Oncology, Auckland City Hospital, Auckland (New Zealand)
- Department of Radiation Oncology, Peter MacCallum Cancer Centre, East Melbourne, Victoria (Australia)
- Department of Radiation Oncology, Royal Prince Alfred Hospital, Camperdown, New South Wales (Australia)
- Oncology Services, Princess Alexandra Hospital, Woolloongabba, Queensland (Australia)
- Radiation Oncology, Royal Adelaide Hospital, Adelaide, South Australia (Australia)
- Radiation Oncology, Calvary Mater Newcastle, Waratah, New South Wales (Australia)
- Department of Radiation Oncology, Radiation Oncology Mater Centre, South Brisbane, Queensland (Australia)
- Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia (Australia)
- Department of Otorhinolaryngology, Middlemore Hospital, Otahuhu, Auckland (New Zealand)
- Department of Oral Health, Auckland City Hospital, Auckland (New Zealand)
- Department of Otorhinolaryngology, Auckland City Hospital, Auckland (New Zealand)
- Psycho-oncology Cooperative Research Group, Univerity of Sydney, Sydney, New South Wales (Australia)
- Adult Oncology Research Centre, Auckland City Hospital, Auckland (New Zealand)
- Biometrics Matters Ltd, Hamilton (New Zealand)
Purpose: To assess the impact of domicile-based humidification on symptom burden during radiation therapy (RT) for head-and-neck (H and N) cancer. Methods and Materials: From June 2007 through June 2011, 210 patients with H and N cancer receiving RT were randomized to either a control arm or to receive humidification using the Fisher and 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.
- OSTI ID:
- 22416457
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 88, Issue 3; Other Information: Copyright (c) 2014 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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