Significant suppression of radiation dermatitis in breast cancer patients using a topically applied adrenergic vasoconstrictor

James F Cleary, Bethany M Anderson, Jens C Eickhoff, Deepak Khuntia, William E Fahl, James F Cleary, Bethany M Anderson, Jens C Eickhoff, Deepak Khuntia, William E Fahl

Abstract

Background: Our previous studies showed that vasoconstrictor applied topically to rat skin minutes before irradiation completely prevented radiodermatitis. Here we report on a Phase IIa study of topically applied NG12-1 vasoconstrictor to prevent radiodermatitis in post-lumpectomy breast cancer patients who received at least 40 Gray to the whole breast using standard regimens.

Methods: Patients had undergone surgery for Stage Ia, Ib, or IIa infiltrating ductal or lobular carcinoma of the breast or ductal carcinoma in situ. NG12-1 formulation was applied topically to the same 50-cm2 treatment site within the radiation field 20 min before each daily radiotherapy fraction.

Results: Scores indicated significant reductions in radiodermatitis at the NG12-1 treatment site versus control areas in the same radiotherapy field. The mean dermatitis score for all subjects was 0.47 (SD 0.24) in the NG12-1-treated area versus 0.72 (SD 0.22) in the control area (P = 0.022). Analysis by two independent investigators indicated radiodermatitis reductions in 9 of the 9 patients with scorable radiodermatitis severity, and one patient with insufficient radiodermatitis to enable scoring. There were no serious adverse events from NG12-1 treatment.

Conclusions: Thirty, daily, NG12-1 treatments, topically applied minutes before radiotherapy, were well tolerated and conferred statistically significant reductions in radiodermatitis severity (P = 0.022).

Trial registration: NCT01263366 ; clinicaltrials.gov.

Keywords: Phase IIa clinical trial; ROS.

Conflict of interest statement

Ethics approval and consent to participate

This study (#NCT01263366; http://www.clinicaltrials.gov) was designed and conducted in accordance with the principles outlined in the Declaration of Helsinki and within the guidelines of Good Clinical Practices, and approved by the University of Wisconsin Health Sciences IRB. Informed consent was obtained from all subjects who participated in the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Radiodermatitis scores for topical NG12-1-treated versus control sites, plotted versus the day of radiation treatment
Fig. 2
Fig. 2
Subject 2000. A, NG12-1 treatment area (arrows) showing skin blanch 20 min after topical NG12-1 application. B, NG12-1 treatment area (arrows) showing reduced radiodermatis on Day 38. The interim analysis score was ++
Fig. 3
Fig. 3
Subject 2004. NG12-1 treatment area (ink marks) showing reduced radiodermatis on Day 30 (Panel a) and Day 35 (Panel b). The interim analysis score was +++
Fig. 4
Fig. 4
Subject 2006. NG12-1 treatment area (ink marks) showing reduced radiodermatis on Day 35. The interim analysis score was +++
Fig. 5
Fig. 5
Subject 2009. A, NG12-1 treatment area (arrows) showing skin blanch 20 min after topical NG12-1 application on Day 4. B, NG12-1 treatment area (arrows) showing reduced radiodermatis on Day 32. The final analysis score was +

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