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

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.

Study Overview

• Status: Recruiting
• Conditions: Radiation Proctitis; Cystitis, Radio Induced; Soft Tissue Radionecrosis (STRN)

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Anders Kjellberg, MD, PhD; Phone Number: +46760657355; Email: anders.kjellberg@regionstockholm.se

Study Locations

• Sweden
  • Stockholm, Sweden, 171 76
    • Recruiting
    • Karolinska University Hospital
    • Contact: Anders Kjellberg, MD, PhD; Phone Number: +46760657355; Email: anders.kjellberg@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EPIC socre	Longitudinal change in symptoms after HBOT measured by EPIC-26 score for bladder and bowel	Baseline to 24 months

Secondary Outcome Measures

Outcome Measure	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	Baseline to 24 months
EQ-5D	Longitudinal change in HRQoL (EQ-5D) after HBOT	Baseline to 24 months
RAND-36	Longitudinal change in HRQoL (RAND-36) after HBOT	Baseline to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose	Association between number of HBOT sessions and outcomes	Baseline to 24 months

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Karolinska Institutet
• Investigators: Principal Investigator: Anders Kjellberg, MD, PhD, Karolinska University Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2040

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Cystitis
• Other Study ID Numbers: K 2026-3891; 4-1184/2026 (Registry Identifier: Karolinska Institutet); 2026-02063-01 (Other Identifier: Etikprövningsmyndigheten)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pseudonomized data will be shared upon resonable request, new ethical approval may be required.
• IPD Sharing Time Frame: From 6 months from each publication and 12 months after last publicarion
• IPD Sharing Access Criteria: By request to principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No