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A feasibility and efficacy trial of a hand-held humidification device in patients undergoing radiotherapy for head and neck cancer

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Abstract

Purpose

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.

Methods

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.

Results

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.”

Conclusions

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.

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Acknowledgements

This work was supported by Vapore, Inc., which provided the devices used in this study, and a National Institutes of Health TL1 Training Grant.

The authors thank Vivian K. Weinberg, Ph.D., for assistance in developing the original statistical study plan and Romobia Hutchinson, B.S., for regulatory and administrative management.

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Correspondence to Sue S. Yom.

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Ghosh, P., Lazar, A.A., Ryan, W.R. et al. A feasibility and efficacy trial of a hand-held humidification device in patients undergoing radiotherapy for head and neck cancer. Support Care Cancer 25, 2611–2618 (2017). https://doi.org/10.1007/s00520-017-3674-z

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  • DOI: https://doi.org/10.1007/s00520-017-3674-z

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