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

Andrew Macann, Tsien Fua, Chris G. Milross, Sandro V. Porceddu, Michael Penniment, Chris Wratten, Hedley Krawitz, Michael Poulsen, Colin I. Tang, Randall P. Morton, K. David Hay, Vicki Thomson, Melanie L Bell, Madeleine T. King, Carol L. Fraser-Browne, Hans Ulrich P Hockey

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Purpose To assess the impact of domicile-based humidification on symptom burden during radiation therapy (RT) for head-and-neck (H&N) cancer. Methods and Materials 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.

Original languageEnglish (US)
Pages (from-to)572-579
Number of pages8
JournalInternational Journal of Radiation Oncology Biology Physics
Volume88
Issue number3
DOIs
StatePublished - Mar 1 2014
Externally publishedYes

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Mucositis
Radiation Oncology
Head and Neck Neoplasms
toxicity
radiation therapy
Radiotherapy
cancer
Area Under Curve
radiation
terminology
Neck
Head
Enteral Nutrition
Terminology
Compliance
grade
Arm
curves
tubes
Benchmarking

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Radiation
  • Cancer Research

Cite this

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. / Macann, Andrew; Fua, Tsien; Milross, Chris G.; Porceddu, Sandro V.; Penniment, Michael; Wratten, Chris; Krawitz, Hedley; Poulsen, Michael; Tang, Colin I.; Morton, Randall P.; Hay, K. David; Thomson, Vicki; Bell, Melanie L; King, Madeleine T.; Fraser-Browne, Carol L.; Hockey, Hans Ulrich P.

In: International Journal of Radiation Oncology Biology Physics, Vol. 88, No. 3, 01.03.2014, p. 572-579.

Research output: Contribution to journalArticle

Macann, A, Fua, T, Milross, CG, Porceddu, SV, Penniment, M, Wratten, C, Krawitz, H, Poulsen, M, Tang, CI, Morton, RP, Hay, KD, Thomson, V, Bell, ML, King, MT, Fraser-Browne, CL & Hockey, HUP 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, vol. 88, no. 3, pp. 572-579. https://doi.org/10.1016/j.ijrobp.2013.11.226
Macann, Andrew ; Fua, Tsien ; Milross, Chris G. ; Porceddu, Sandro V. ; Penniment, Michael ; Wratten, Chris ; Krawitz, Hedley ; Poulsen, Michael ; Tang, Colin I. ; Morton, Randall P. ; Hay, K. David ; Thomson, Vicki ; Bell, Melanie L ; King, Madeleine T. ; Fraser-Browne, Carol L. ; Hockey, Hans Ulrich P. / 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. In: International Journal of Radiation Oncology Biology Physics. 2014 ; Vol. 88, No. 3. pp. 572-579.
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abstract = "Purpose To assess the impact of domicile-based humidification on symptom burden during radiation therapy (RT) for head-and-neck (H&N) cancer. Methods and Materials 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.",
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T1 - Phase 3 trial of domiciliary humidification to mitigate acute mucosal toxicity during radiation therapy for head-and-neck cancer

T2 - First Report of Trans Tasman Radiation Oncology Group (TROG) 07.03 RadioHUM study

AU - Macann, Andrew

AU - Fua, Tsien

AU - Milross, Chris G.

AU - Porceddu, Sandro V.

AU - Penniment, Michael

AU - Wratten, Chris

AU - Krawitz, Hedley

AU - Poulsen, Michael

AU - Tang, Colin I.

AU - Morton, Randall P.

AU - Hay, K. David

AU - Thomson, Vicki

AU - Bell, Melanie L

AU - King, Madeleine T.

AU - Fraser-Browne, Carol L.

AU - Hockey, Hans Ulrich P

PY - 2014/3/1

Y1 - 2014/3/1

N2 - Purpose To assess the impact of domicile-based humidification on symptom burden during radiation therapy (RT) for head-and-neck (H&N) cancer. Methods and Materials 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.

AB - Purpose To assess the impact of domicile-based humidification on symptom burden during radiation therapy (RT) for head-and-neck (H&N) cancer. Methods and Materials 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.

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