Number of days from radiotherapy start to enrollment†
14 (± 6)
14 (± 7)
14 (± 6)
0.721
Tumor site‡
0.400
Oral cavity
20 (35.7)
7 (26.9)
13 (43.3)
Larynx
19 (33.9)
9 (34.6)
10 (33.3)
Pharynx
12 (21.4)
7 (26.9)
5 (16.7)
Larynx, pharynx
4 (7.1)
3 (11.5)
1 (3.3)
Nasal cavity
1 (1.8)
0 (0.0)
1 (3.3)
T stage‡
> 0.900
0
2 (3.6)
1 (3.8)
1 (3.3)
1
1 (1.8)
1 (3.8)
0 (0.0)
2
13 (23.2)
6 (23.1)
7 (23.3)
3
17 (30.4)
8 (30.8)
9 (30.0)
4
8 (14.3)
3 (11.5)
5 (16.7)
4a
10 (17.9)
4 (15.4)
6 (20.0)
4b
4 (7.1)
2 (7.7)
2 (6.7)
X
1 (1.8)
1 (3.8)
0 (0.0)
N category‡
0.200
0
18 (32.1)
12 (46.2)
6 (20.0)
1
5 (8.9)
3 (11.5)
2 (6.7)
2
10 (17.9)
4 (15.4)
6 (20.0)
2b
11 (19.6)
2 (7.7)
9 (30.0)
2c
3 (5.4)
2 (7.7)
1 (3.3)
3
8 (14.3)
3 (11.5)
5 (16.7)
3b
1 (1.8)
0 (0.0)
1 (3.3)
M category‡
0.700
0
53 (94.6)
24 (92.3)
29 (96.7)
1
2 (3.6)
1 (3.8)
1 (3.3)
X
1 (1.8)
1 (3.8)
0 (0.0)
Data are presented as † mean (± standard deviation); * median (interquartile range, IQR), or as an ‡ absolute number (percentage of the total number of respondents in the subject group)
Declarations
Author contributions
ZG, JR, and NG: Investigation, Writing—review & editing. AŠ: Conceptualization, Resources, Methodology, Supervision. MM: Conceptualization, Methodology, Supervision, Writing—original draft. ATA: Conceptualization, Writing—original draft. UG: Conceptualization, Data curation, Software, Formal analysis, Supervision, Visualization, Methodology, Writing—original draft. All authors approved the final version of the manuscript.
Conflicts of interest
Aziz Šukalo, Meliha Mehić, Amna Tanović Avdić, and Una Glamočlija disclose the following relationships—employees of Bosnalijek d.d., a pharmaceutical company producing lysozyme-based products.
Ethical approval
The study was registered with the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina under the protocol number LCS-OM-01. The clinical study was approved by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina, number 08-07.5-6730-1/20 on July 20, 2020.
Consent to participate
Informed consent to participate in the study was obtained from all participants.
Consent to publication
Not applicable.
Availability of data and materials
The datasets generated for this study are available from the corresponding author upon reasonable request.
Funding
The authors declare that this study was supported by Bosnalijek d.d. (a company that is a producer of lysozyme-based products). Bosnalijek d.d. had a role in the design of the study; in the collection, analyses, and interpretation of data; in the writing of the manuscript, and in the decision to publish the results. The data and results of this study are not affected by the interest of the Bosnalijek d.d.
Open Exploration maintains a neutral stance on jurisdictional claims in published institutional affiliations and maps. All opinions expressed in this article are the personal views of the author(s) and do not represent the stance of the editorial team or the publisher.
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