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Radiat Oncol. 2017 Dec 22;12(1):201. doi: 10.1186/s13014-017-0940-7.

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

Author information

1
Department of Medicine, University of Wisconsin, Madison, WI, USA.
2
Department of Human Oncology, University of Wisconsin, Madison, WI, USA.
3
Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA.
4
Varian Medical Systems, Palo Alto, CA, USA.
5
Valley Medical Oncology, Pleasanton, CA, USA.
6
Department of Oncology, Wisconsin Institutes of Medical Research, University of Wisconsin-Madison, 1111 Highland Avenue, Madison, WI, USA. fahl@oncology.wisc.edu.

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

PMID:
29273054
PMCID:
PMC5741935
DOI:
10.1186/s13014-017-0940-7
[Indexed for MEDLINE]
Free PMC Article

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