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| ID | Type | Description | Link |
|---|---|---|---|
| 4-1184/2026 | Registry Identifier | Karolinska Institutet | |
| 2026-02063-01 | Other Identifier | Etikprövningsmyndigheten |
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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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Radiotherapy cures many cancers but can cause late radiation-induced tissue injury (LRTI), leading to long-term symptoms from the bladder and bowel and reduced health-related quality of life (HRQoL). Hyperbaric oxygen therapy (HBOT) is an established treatment that reduces chronic inflammation and promotes tissue repair. Randomized studies have demonstrated improvements in symptoms and quality of life, but only a small proportion of affected patients receive HBOT.
This study aims to longitudinally describe a cohort of patients with LRTI treated with HBOT at Karolinska University Hospital and to analyze associations between treatment, timing, and patient characteristics. The goal is to improve understanding of which patients benefit most from HBOT and when treatment should be initiated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective cohort | Retrospective cohort (n ≈ 120): existing quality registry and medical records | ||
| Prospective cohort | Prospective cohort (target n ≈ 1,000): patients included after ethical approval |
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| Measure | Description | Time Frame |
|---|---|---|
| EPIC socre | Longitudinal change in symptoms after HBOT measured by Extended Prostate Index Composite 26 items (EPIC-26) score for bladder and bowel. Score desrcibe a composite of symtoms related to LRTI from 0-100, where 0 is worse symtoms and 100 is no symtoms. | Baseline to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Timing | Association between timing variables (time from radiation to HBOT) and treatment response | Baseline to 24 months |
| Phenotype | Association between baseline factors (sex, diagnosis, dose, comorbidity) and outcomes |
| Measure | Description | Time Frame |
|---|---|---|
| Dose | Association between number of HBOT sessions and outcomes | Baseline to 24 months |
Inclusion Criteria:
Exclusion Criteria:
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Cohort 1 - Retrospective cohort Cohort 1 includes all patients (n = 120) with late radiation-induced tissue injury treated with HBOT and registered in the unit's clinical quality registry during the defined study period.
Cohort 2 - Prospective cohort To generate robust real-world evidence and enable identification of predictive factors with adequate statistical precision, data collection is planned for approximately 1,000 patients treated with HBOT at Karolinska University Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anders Kjellberg, MD, PhD | Contact | +46760657355 | anders.kjellberg@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Anders Kjellberg, MD, PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Stockholm | 171 76 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40291346 | Background | Oscarsson N, Rosen A, Muller B, Koskela LR, Giglio D, Kjellberg A, Ettala O, Seeman-Lodding H. Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): long-term follow-up of a randomised controlled, phase 2-3 trial. EClinicalMedicine. 2025 Apr 19;83:103214. doi: 10.1016/j.eclinm.2025.103214. eCollection 2025 May. | |
| 31537473 |
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Pseudonomized data will be shared upon resonable request, new ethical approval may be required.
From 6 months from each publication and 12 months after last publicarion
By request to principal investigator
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| ID | Term |
|---|---|
| D003556 | Cystitis |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Baseline to 24 months |
| EQ-5D | Longitudinal change in HRQoL (EQ-5D) evaluated by EuorQoL 5 Dimensions (EQ-5D) after HBOT. EQ-5D index range from 0-1 with country specific vale sets., in Sweden the range is -0.3-1). EQ-5D also has a visual analoge scale (EQ-VAS) from 0-100, where 0 is low and 100 is high HRQoL. | Baseline to 24 months |
| RAND-36 | Longitudinal change in HRQoL evaluated by RAND 36-Item Health Survey (RAND-36) after HBOT. RAND-36 evaluates overall well-being across eight physical, emotional, and social domains. Raw answers are converted to a scale from 0 to 100, where higher scores indicate a more favorable or better health state. | Baseline to 24 months |
| Oscarsson N, Muller B, Rosen A, Lodding P, Molne J, Giglio D, Hjelle KM, Vaagbo G, Hyldegaard O, Vangedal M, Salling L, Kjellberg A, Lind F, Ettala O, Arola O, Seeman-Lodding H. Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2-3 trial. Lancet Oncol. 2019 Nov;20(11):1602-1614. doi: 10.1016/S1470-2045(19)30494-2. Epub 2019 Sep 16. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |