Soft Tissue Radiation Injury; Patient Reported Evaluation in a Single Centre Cohort Study (STRIPE)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Adult patients (>18 years old)
Late radiation tissue injury
Treated with HBOT
Disqualifiers
Requested not to be included in the study (Retrospective cohort)
Not signed informed consent (Prospective cohort)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 2 trial groupsGroup A: Retrospective cohort
Group B: Prospective cohort
Trial outcomes
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.
Time frame
Baseline to 24 monthsSecondary outcomes
1
Timing
Association between timing variables (time from radiation to HBOT) and treatment response
Time frame
Baseline to 24 months2
Phenotype
Association between baseline factors (sex, diagnosis, dose, comorbidity) and outcomes
Time frame
Baseline to 24 months3
EQ-5D
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.
Time frame
Baseline to 24 months4
RAND-36
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.
Time frame
Baseline to 24 monthsOther outcomes
1
Dose
Association between number of HBOT sessions and outcomes
Time frame
Baseline to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska University Hospital
Lead sponsor
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov