Sodium deoxyribonucleate for reducing acute bladder toxicity during radiotherapy in patients with endometrial cancer: a pilot randomized controlled study

Ivashin A.A., Skopin P.I., Deryabina O.N., Piskunova A.V.

National Research Ogarev Mordovia State University, Saransk, Russia

Background: Radiotherapy for endometrial cancer may be associated with acute bladder toxicity, highlighting the need for effective preventive strategies.
Objective: To assess the frequency and severity of acute bladder toxicity in patients with endometrial cancer receiving radiotherapy with the addition of sodium deoxyribonucleate.
Material and methods: This pilot randomized controlled study included 26 patients with stage I–II endometrial cancer who were randomized in a 1:1 ratio. All patients had previously undergone surgery; radiotherapy was administered postoperatively as adjuvant treatment. The experimental group received external beam radiotherapy plus sodium deoxyribonucleate 75 mg intramuscularly every other day for 15–22 injections, whereas the control group received standard external beam radiotherapy. Acute toxicity was assessed using the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0), lower urinary tract symptom questionnaires, voiding diaries, urinalysis, and cystoscopic findings.
Results: Radiation cystitis of CTCAE v5.0 grade ≥1 was observed in 4 of 13 patients in the experimental group and 8 of 13 patients in the control group: 30,8% versus 61,5%; relative risk, 0,50; 95% confidence interval, 0,20–1,26 (p=0,238). CTCAE v5.0 grade ≥2 cystitis occurred in 1 of 13 and 2 of 13 patients, respectively. Patient-reported outcomes, voiding diary data, urinalysis findings, and cystoscopic findings also showed directionally consistent differences favoring the experimental group.
Discussion: Given the small sample size and the lack of statistical significance for the primary outcome, the observed differences should be interpreted as a hypothesis-generating signal requiring confirmation in a larger adequately powered study.
Conclusion: The addition of sodium deoxyribonucleate to radiotherapy was associated with a lower frequency and severity of acute bladder toxicity in patients with endometrial cancer.

For citations: Ivashin A.A., Skopin P.I., Deryabina O.N., Piskunova A.V. Sodium deoxyribonucleate for reducing acute bladder toxicity during radiotherapy in patients with endometrial cancer: a pilot randomized controlled study. Pharmateca. 2026;33(6):74-82. (In Russ.). DOI: https://dx.doi.org/10.18565/pharmateca.2026.6.74-82

Authors’ contribution: A.A. Ivashin – development of the study concept and design; formulation of the aim and objectives of the study; registration of adverse events; systematization of primary medical data; clinical interpretation of the obtained results; preparation and scientific editing of the manuscript. P.I. Skopin – study concept and design, formulation of the aim and objectives, clinical interpretation of the results, manuscript preparation and scientific editing. O.N. Deryabina – statistical analysis, calculation of relative risks, confidence intervals and statistical significance values, preparation of tables and interpretation of quantitative results. A.V. Piskunova – literature review, reference list preparation, drafting of the Introduction and Discussion sections, and editing of the Russian and English parts of the manuscript.
Conflicts of interest: The authors declare that they have no financial or other actual or potential conflicts of interest that could influence the study results or their interpretation.
Funding: The study was conducted without any sponsorship.
Ethical Approval: The study was approved by the Local Ethics Committee at National Research Ogarev Mordovia State University (Protocol No. 136 dated January 31, 2025).
Patient Consent for Publication: All patients provided informed consent for the publication of their data.
Authors’ Data Sharing Statement: The data supporting the findings of this study are available upon request from the corresponding author after approval from the principal investigator.

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About the Authors

Artem A. Ivashin, Senior Lecturer, Department of Oncology with a Course on Diagnostic Radiology and Radiation Therapy, National Research Ogarev Mordovia State University, Saransk, Russia; a.iwashin2017@yandex.ru, ORCID: https://orcid.org/0000-0001-7842-1954, AuthorID: 999602,
eLibrary SPIN: 1349-4515 (corresponding author)
Pavel I. Skopin, Dr. Sci. (Med.), Professor, Director of the Medical Institute, National Research Ogarev Mordovia State University, Saransk, Russia; skopinpi@mail.ru, ORCID: https://orcid.org/0000-0001-6662-5052, AuthorID: 551027, eLibrary SPIN: 5755-3990
Olga N. Deryabina, Dr. Sci. (Med.), Professor, Head of the Department of Oncology with a Course on Diagnostic Radiology and Radiation Therapy, National Research Ogarev Mordovia State University, Saransk, Russia; dr.deryabina@gmail.com, ORCID: https://orcid.org/0000-0002-8814-3369, AuthorID: 611966, eLibrary SPIN: 9472-0603
Alina V. Piskunova, 2nd-year Medical Resident, Medical Institute, National Research Ogarev Mordovia State University, Saransk, Russia; alpkn@mail.ru,
ORCID: https://orcid.org/0000-0002-8869-5091, AuthorID: 1170769, eLibrary SPIN: 8020-5453

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