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NCT Number: NCT07611864

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.

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Key information

Conditions

Cystitis, Radio Induced Cystitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Radiation Proctitis Soft Tissue Radionecrosis (STRN) Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, 171 76, Sweden

Location status: Recruiting

Location contact

Anders Kjellberg, MD, PhD

CONTACT

[email protected]

+46760657355

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Timing

    Time frame: Baseline to 24 months

    Association between timing variables (time from radiation to HBOT) and treatment response

  2. Phenotype

    Time frame: Baseline to 24 months

    Association between baseline factors (sex, diagnosis, dose, comorbidity) and outcomes

  3. EQ-5D

    Time frame: 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.

  4. RAND-36

    Time frame: 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.

Other outcomes

  1. Dose

    Time frame: Baseline to 24 months

    Association between number of HBOT sessions and outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

Anders Kjellberg, MD, PhD

CONTACT

[email protected]

+46760657355

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Acronym: karolinskaUH

Important dates

Study start
2026
Primary completion
2030
Study completion
2040
First posted
May 28, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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