Photobiomodulation for the management of radiation dermatitis: the DERMIS trial, a pilot study of MLS® laser therapy in breast cancer patients

Abstract

Purpose

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).

Methods

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).

Results

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.

Conclusions

These findings suggest that LT might be effective to manage acute RD and warrant further research.

Trial registration

Clinical trial number: NCT01932073. https://clinicaltrials.gov/ct2/show/NCT01932073.

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Notes

  1. 1.

    The MLS® combines a laser diode emitting at 808 nm in continuous mode with a laser emitting at 905 nm in pulsed mode. Continuous laser emissions act on inflammation, stimulates blood and lymphatic circulation, and induces fast re-absorption of fluid build-ups; while pulsed laser emissions have an immediate effect on pain, since they are able to induce analgesia interfering with the very transmission of the pain impulse to the higher brain centers. Thanks to this combination, these various therapeutic effects not only take place at the same time but also reciprocally reinforce each other, resulting in rapid physiological effects and symptoms relief. Moreover, both wavelengths fall into the so-called optical window where the effective tissue penetration of light is maximized [24]. LT using synchronized wavelengths of 808 and 905 nm will reach both the epidermal and dermal layers and will be able to stimulate the self-renewing property of the epidermis and the production of collagen tissue by the dermal fibroblasts.

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Acknowledgments

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).

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Correspondence to Sandrine Censabella.

Ethics declarations

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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Censabella, S., Claes, S., Robijns, J. et al. Photobiomodulation for the management of radiation dermatitis: the DERMIS trial, a pilot study of MLS® laser therapy in breast cancer patients. Support Care Cancer 24, 3925–3933 (2016). https://doi.org/10.1007/s00520-016-3232-0

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Keywords

  • Breast neoplasms
  • Low level laser therapy
  • Photobiomodulation
  • Radiation
  • Radiation oncology
  • Radiotherapy-induced skin reactions