Censabella, S., Claes, S., Robijns, J., Bulens, P., & Mebis, J. (2016). Photobiomodulation for the management of radiation dermatitis: The DERMIS trial, a pilot study of MLS(®) laser therapy in breast cancer patients. Supportive Care in Cancer, 24, 3925–3933. 

DOI Link

Study Purpose

To assess the effects of Multiwave Lock System low-level laser therapy in the management of acute radiation dermatitis

Intervention Characteristics/Basic Study Process

All patients received standard skin care including hydroactive colloid gel thre times daily throughout radiation therapy and self-adhesive silicone foam dressing for dry or moist desquamation. Those in the laser therapy group also received six sessions twice a week starting from fraction 20 of radiation. Results from the laser group were compared to that of a historical control group who had only usual care.

Sample Characteristics

  • N = 79   
  • MEAN AGE = 55 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Patients with breast cancer; most had stage I–II disease; slightly more than one-third had chemotherapy prior to radiotherapy.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Belgium

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Prospective, quasiexperimental with historical control comparison

Measurement Instruments/Methods

  • Radiation Therapy Oncology Group (RTOG) grading
  • Radiotherapy-Induced Skin Reaction Assessment Scale (RISRA)
  • Skindex-16

Results

RTOG scores in the control group increased over time but remained stable in the laser group. The difference between groups was significant (p < 0.005). There were no cases of greater than grade 2 skin toxicity. Analysis of change in RISRA scores showed improvement in subjective scores in the laser group (p = 0.023) and less score increase overall in the laser group (p < 0.03).

Conclusions

This type of low-level laser therapy was shown to be beneficial in reducing the severity of radiodermatitis among women being treated for breast cancer.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)
 

Nursing Implications

The use of low-level laser therapy may have some benefit for the management of radiodermatitis. The promising findings from this study warrant additional well designed research.