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Table 1 Demographics and Treatment details of Breast Cancer Study Population

From: A monocentric, open-label randomized standard-of-care controlled study of XONRID®, a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients

Characteristics SOC (N = 20) Xonrid® + SOC (N = 20) p-Value
Gender Females 20 (100.0%) 20 (100.0%) n.a.
Age N 20 20 0.7
Mean (SD) 49.01 (4.54) 49.56 (4.80)
Median 48.99 49.03
Range 38.26–57.75 40.38–57.94
ECOG performance status 0 20 (100.0%) 20 (100.0%) n.a.
Concomitant medications for comorbidities Yes 12 (60.0%) 9 (45.0%) 0.3
No 8 (40.0%) 11 (55.0%)
Histology DCIS 2 (10.0%) 3 (15.0%) 0.4
Invasive Ductal Carcinoma 18 (90.0%) 17 (85%)
Stage TNM VIII Edition DCIS 2 (10.0%) 3 (15.0%) 0.5
IA 11 (55.0%) 16 (80.0%)
IB 1 (5%) 1 (5%)
II A 3 (15%)  
IIB 3 (15%)  
Prescribed total dose/ N° of fractions 50 / 25 2 (10.0%) 3 (15.0%) 0.6
60 / 30 18 (90.0%) 17 (85.0%)
Baseline Erythema assessment - Skin toxicity grade No erythema 20 (100.0%) 20 (100.0%) 0.3
SKINDEX-16 - Symptom score N 20 20 0.3
Mean (SD) 0.06 (0.23) 0.16 (0.40)
Median 0.00 0.00
Min - Max 0.00–1.00 0.00–1.50
SKINDEX-16 - Emotional score N 20 20 0.9
Mean (SD) 0.19 (0.46) 0.16 (0.31)
Median 0.00 0.00
Min - Max 0.00–1.71 0.00–1.00
SKINDEX-16 - Functional score N 20 20 0.6
Mean (SD) 0.08 (0.28) 0.16 (0.54)
Median 0.00 0.00
Min - Max 0.00–1.20 0.00–2.40