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Table 2 Demographics and Treatment details of Head and Neck 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 4 (20.0%) 4 (20.0%) 1.0
Males 16 (80.0%) 16 (80.0%)  
Age N 20 20 0.6
Mean (SD) 57.49 (12.34) 55.73 (12.46)
Median 58.36 59.18
Range 32.32–79.24 24.70–76.61
ECOG performance status 0 20 (100.0%) 20 (100.0%) n.a.
Concomitant medications for comorbidities Yes 10 (50.0%) 9 (45.0%) 0.7
No 10 (50.0%) 11 (55.0%)
Cancer Subsite Hypopharynx   1 (5.0%) 0.07
Larynx 2 (10.0%) 2 (10.0%)
Nasopharynx 10 (50.0%) 5 (25.0%)
Oral Cavity 4 (20.0%)  
Oropharynx 4 (20.0%) 10 (50.0%)
Paranasal Sinuses   2 (10.0%)
Stage (TNM VIII Edition)
Clinical   14 (70%) 18 (90%) 0.5
I/II 1 (7.2%) 2 (11.1%)
III/IV 13 (92.8%) 16 (88.9%)
Pathological   6 (30%) 2 (10%)
I/II 0 0
III/IV 6 (100%) 2 (100%)
Aim of radiation treatment
Definitive   14 (70.0%) 16 (80.0%) 0.5
Postoperative   6 (30.0%) 4 (20.0%)
Prescribed total dose/ N° of fractions
HD-PTV Total planned dose / N° of fractions 60.00 / 30.00 2 (10.0%) 1 (5.0%) 0.6
64.50 / 30.00 1 (5.0%)  
66.00 / 33.00 3 (15.0%) 2 (10.0%)
69.96 / 33.00 14 (70.0%) 16 (80.0%)
70.00 / 35.00   1 (5.0%)
ID-PTV Total planned dose / N° of fractions 0.00 7 (36.8%) 8 (42.1%) 0.5
59.40 / 33.00 10 (52.6%) 1 (52.6%)
60.00 / 30.00 1 (5.3%)  
66.00 / 33.00 1 (5.3%)  
LD-PTV Total planned dose / N° of fractions 54.00 / 30.00 3 (15.0%) 1 (5.0%) 0.4
56.00 / 35.00   1 (5.0%)
56.10 / 33.00 14 (70.0%) 17 (85.0%)
59.40 / 33.00 3 (15.0%) 1 (5.0%)
Baseline Erythema assessment - Skin toxicity grade No erythema 20 (100.0%) 20 (100.0%) n.a.
SKINDEX-16 - Symptom score N 19 20 0.3
Mean (SD) 0.00 (0.00) 0.05 (0.22)
Median 0.00 0.00
Min - Max 0.00–0.00 0.00–1.00
SKINDEX-16 - Emotional score N 19 20 0.02*
Mean (SD) 0.07 (0.20) 0.79 (1.27)
Median 0.00 0.00
Min - Max 0.00–0.71 0.00–5.14
SKINDEX-16 - Functional score N 19 20 0.2
Mean (SD) 0.08 (0.37) 0.56 (1.39)
Median 0.00 0.00
Min - Max 0.00–1.60 0.00–6.00
Concomitant Chemotherapy Yes 16 (80.0%) 17 (85.0%) 0.7
No 4 (20.0%) 3 (15.0%)