An observational study in Cystitis, Radio Induced, Soft Tissue Radionecrosis (STRN) and Radiation Proctitis, sponsored by Karolinska University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Karolinska University Hospital · Observational
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.
69 studies on the registry are indexed under Cystitis; 17 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 216 across 15 observational studies indexed under Cystitis.
Browse Cystitis studies →Karolinska University Hospital is the lead sponsor of 279 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Retrospective cohort (n ≈ 120): existing quality registry and medical records
Prospective cohort (target n ≈ 1,000): patients included after ethical approval
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.
Time frame: Baseline to 24 months
Timing
Association between timing variables (time from radiation to HBOT) and treatment response
Time frame: Baseline to 24 months
Phenotype
Association between baseline factors (sex, diagnosis, dose, comorbidity) and outcomes
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 24 months
Dose
Association between number of HBOT sessions and outcomes
Time frame: Baseline to 24 months
Plan to share: Yes — Pseudonomized data will be shared upon resonable request, new ethical approval may be required.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: From 6 months from each publication and 12 months after last publicarion
Access criteria: By request to principal investigator
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