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

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.

NCT Number	NCT07611864
Lead Sponsor	Karolinska University Hospital Collaborators: Karolinska Institutet
Conditions	Cystitis, Radio Induced, Soft Tissue Radionecrosis (STRN), Radiation Proctitis
Enrollment	1,000 participants
Start Date	2026-05-05
Primary Completion	2030-12-31 (estimated)
Study Completion	2040-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-03