Soft Tissue Radiation Injury; Patient Reported Evaluation in a Single Centre Cohort Study (STRIPE)

NCT07611864 — Recruiting, 1000 participants, Karolinska University Hospital

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Registry	NCT07611864, acronym karolinskaUH
Status	Recruiting
Study type	Observational
Enrollment	1000 (Estimated)
Sponsor	Karolinska University Hospital (Other); collaborators: Karolinska Institutet
Conditions	Cystitis, Radio Induced, Soft Tissue Radionecrosis (STRN), Radiation Proctitis
Dates	start 2026-05-05, primary completion 2030-12-31 (estimated), completion 2040-12-31 (estimated), first posted 2026-05-28, last updated 2026-06-03
Locations	1 site in Sweden

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
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

+Outcome measures

Primary outcomes

EPIC socre [Baseline to 24 months]: 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.

Secondary outcomes

Timing [Baseline to 24 months]: Association between timing variables (time from radiation to HBOT) and treatment response
Phenotype [Baseline to 24 months]: Association between baseline factors (sex, diagnosis, dose, comorbidity) and outcomes
EQ-5D [Baseline to 24 months]: 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.
RAND-36 [Baseline to 24 months]: 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.

Other outcomes

Dose [Baseline to 24 months]: Association between number of HBOT sessions and outcomes

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Adult patients (>18 years old)
* Late radiation tissue injury
* Treated with HBOT

Exclusion Criteria:

* Requested not to be included in the study (Retrospective cohort)
* Not signed informed consent (Prospective cohort)

+Locations (1)

Facility	City	Country	Status
Karolinska University Hospital	Stockholm	Sweden	Recruiting

+Publications

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. PMID 40291346
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. PMID 31537473

+Investigators

Anders Kjellberg, MD, PhD, Principal investigator, Karolinska University Hospital