Photobiomodulation for the management of radiation dermatitis: the DERMIS trial, a pilot study of MLS® laser therapy in breast cancer patients
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The aim of this study was to assess the effectiveness and acceptability of photobiomodulation using MLS® laser therapy (LT) in the management of acute radiation dermatitis (RD).
We compared two successive groups of breast cancer patients undergoing identical radiotherapy regimens post-lumpectomy. Both groups received our standard skin care but the second group received six additional LT sessions (beam area 19.635 cm2, 0.168 W/cm2, 4 J/cm2), starting at fraction 20 of radiotherapy (control and LT group, N = 41 and 38, respectively). The clinical outcomes were the severity of RD (using the Radiation Therapy Oncology Group [RTOG] criteria and the Radiotherapy-Induced Skin Reaction Assessment Scale [RISRAS]) and dermatology-specific quality of life (Skindex-16) before the start of LT and at the end of radiotherapy. Secondary outcomes were patients’ ratings of skin care or LT (pleasantness, soothing effect, and global satisfaction).
Skin toxicity was equivalent between the groups before the start of LT but significantly differed at the end of radiotherapy, with an aggravation in the control but not in the LT group (e.g., 29 versus 3 % of RTOG grade 2 RD, respectively, P < 0.005). We found no significant group differences with respect to quality of life. However, the RISRAS subjective score decreased in the LT group only, implying a decreased impact of RD on patients’ quality of life. Finally, patients’ ratings were significantly higher for LT than for standard care.
These findings suggest that LT might be effective to manage acute RD and warrant further research.
Clinical trial number: NCT01932073. https://clinicaltrials.gov/ct2/show/NCT01932073.
KeywordsBreast neoplasms Low level laser therapy Photobiomodulation Radiation Radiation oncology Radiotherapy-induced skin reactions
The present work had no specific funding. The authors wish to thank the nursing staff of the Jessa Hospital Radiotherapy Department for their invaluable support and assistance in carrying out this study. We are also thankful to anonymous reviewers for their helpful comments on a previous draft of this manuscript. Preliminary or partial results of this research have been presented at the 39th ESMO Annual Meeting and at the 2015 MASCC/ISOO Annual Meeting (Censabella et al., 2014, Ann Oncol 25: iv517-iv541-1533P; Censabella et al., 2015, Support Care Cancer 23: S260-S261, respectively).
Compliance with ethical standards
The study protocol was approved by our local Medical Ethics Committees and was registered at the National Institutes of Health (www.clinicaltrials.gov No. NCT01932073). All participants provided written informed consent prior to their inclusion in the study.
Conflict of interest
Prof. J. Mebis and J. Robijns report financial sponsorship from ASA srl subsequent to this work.
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