Cystitis, Radio Induced, Radiation Proctitis, Soft Tissue Radionecrosis (STRN)
Conditions
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.
Interventions
None listed
Sponsors
Karolinska University Hospital
Karolinska Institutet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Sweden
Contacts
CONTACTAnders Kjellberg, MD, PhD
PRINCIPAL_INVESTIGATORAnders Kjellberg, MD, PhD
Karolinska University Hospital
Outcome results
None listed