Cystitis, Radio InducedkarolinskaUHNCT07611864
Soft Tissue Radiation Injury; Patient Reported Evaluation in a Single Centre Cohort Study (STRIPE)
An observational study of Cystitis, Radio Induced and Soft Tissue Radionecrosis (STRN), run by Karolinska University Hospital at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystitis, Radio Induced, Soft Tissue Radionecrosis (STRN), Radiation Proctitis
- How many people
- 1,000 participants
- Where
- 1 siteSweden
- Study dates
- 5 May 2026to 31 Dec 2040
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients (>18 years old)
- Late radiation tissue injury
- Treated with HBOT
Who cannot join
- Requested not to be included in the study (Retrospective cohort)
- Not signed informed consent (Prospective cohort)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 171 76
Anders Kjellberg, MD, PhD, +46760657355, anders.kjellberg@regionstockholm.se
About this study
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.
- Medical subject headings
- Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 24 months
Secondary outcomes (4)
Timing
Association between timing variables (time from radiation to HBOT) and treatment response
Measured: Baseline to 24 months
Phenotype
Association between baseline factors (sex, diagnosis, dose, comorbidity) and outcomes
Measured: Baseline to 24 months
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.
Measured: Baseline to 24 months
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.
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start5 May 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cystitis, Radio InducedStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Anders Kjellberg, MD, Karolinska University Hospital
- Investigators
- Anders Kjellberg, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611864
- Sponsor's protocol ID
- K 2026-3891
- Other IDs
- 4-1184/2026, 2026-02063-01
- Acronym
- karolinskaUH
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonomized data will be shared upon resonable request, new ethical approval may be required.
Publications
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.
PubMed 40291346Oscarsson 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.
PubMed 31537473
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Radiation Injury; Patient Reported Evaluation in a Single Centre Cohort Study (STRIPE)
- ClinicalTrials.gov ID
- NCT07611864
- Acronym / sponsor ID
- karolinskaUH / K 2026-3891
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 5 May 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adult patients (>18 years old)
- Late radiation tissue injury
- Treated with HBOT
Key exclusion criteria (2 listed)
- Requested not to be included in the study (Retrospective cohort)
- Not signed informed consent (Prospective cohort)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EPIC socre
Time frame: 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.
4 secondary outcomes
Timing
Time frame: Baseline to 24 months
Phenotype
Time frame: Baseline to 24 months
EQ-5D
Time frame: Baseline to 24 months
RAND-36
Time frame: Baseline to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 40291346Oscarsson 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.
- Background: PubMed 31537473Oscarsson 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.
- Individual participant dataSharing planned: Yes. Pseudonomized data will be shared upon resonable request, new ethical approval may be required.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anders Kjellberg, MD, PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystitis, Radio Induced and Soft Tissue Radionecrosis (STRN), run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anders Kjellberg, MD, PhD (+46760657355, anders.kjellberg@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EPIC socre (time frame: Baseline to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07611864, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.