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

NCT07611864 | Recruiting

• 3 other identifiers: K 2026-38914-1184/20262026-02063-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystitis, Radio Induced; Soft Tissue Radionecrosis (STRN); Radiation Proctitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Timing

  Baseline to 24 months

• Phenotype

  Baseline to 24 months

• EQ-5D

  Baseline to 24 months

• RAND-36

  Baseline to 24 months

Other Outcomes (1)

• Dose

  Baseline to 24 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 171 76, Sweden

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cystitis

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Anders Kjellberg, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders Kjellberg, MD, PhD

CONTACT

+46760657355; anders.kjellberg@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2040
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From 6 months from each publication and 12 months after last publicarion
• Access Criteria: By request to principal investigator

Locations

SE (1)