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Recruiting
NCT07611864
Soft Tissue Radiation Injury; Patient Reported Evaluation in a Single Centre Cohort Study (STRIPE)
Conditions: Cystitis, Radio Induced, Soft Tissue Radionecrosis (STRN), Radiation Proctitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1000
Sponsor: Karolinska University Hospital
Location: Karolinska University Hospital Stockholm
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.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT07611864). StuddyBuddy aggregates publicly available trial information.