NCT01659723

Brief Summary

The primary objective of this study is to assess the relief of symptoms after Hyperbaric Oxygen Therapy (HBOT) in patients with late radiation cystitis by having Expanded Prostate cancer Index Composite (EPIC)symptom estimation scale as primary variable. Study hypothesis:

  • HBOT can reduce or reverse the change or otherwise limit the damage of the bladder function and/or structure, which arose as a result of radiation therapy of cancer in the pelvic region organs.
  • The effects of HBOT are associated with relief of symptoms that, at least in part, is related to the reduction of the extent of the radiation damage.
  • Vascular density increases, fibrosis prevalence and inflammatory activity are reduced as a sign of an improved function of the mucosa.
  • Treatment results of HBOT remains, in whole or in part, during the follow-up (residual effect)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_2

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2018

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

6 years

First QC Date

August 2, 2012

Last Update Submit

June 24, 2019

Conditions

Cystitis, Radio Induced

Keywords

Radio therapySTRIUrinary bladderHyperbaric Oxygen

Outcome Measures

Primary Outcomes (1)

  • EPIC (Expanded Prostate cancer Index Composite)

    EPIC was developed to measure health-related quality of life among men with prostate cancer (22) modified to enhance sensitivity to therapy effects. It comprises four summary domains; urinary, bowel, sexual and hormonal. The primary objective of this study is to assess the relief of symptoms after HBOT in patients with late radiation cystitis by having EPIC symptom estimation scale as primary variable, comparing results between group A (post treatment) and group B (pre treatment). All patients (Group A and B) will complete EPIC and SF-36 in a post-study long-term follow-up. This is done yearly for 5 years (18, 30, 42, 54 and 66 months post inclusion).

    At inclusion, 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B) and for long-term follow-up as specified under "description"

Secondary Outcomes (4)

  • Microscopic assessment

    At inclusion and 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B)

  • RTOG (Radiation Toxicity Grade by Radiation Therapy Oncology Group)

    At inclusion and 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B)

  • SF-36 (Short Form Health Survey 36)

    At inclusion, 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B) and for long-term follow-up as specified under "description"

  • Adverse events

    Every day during HBOT (8 weeks).

Study Arms (2)

A - Immediate start

ACTIVE COMPARATOR

Start of treatment within 6 weeks of inclusion in the study. 100% oxygen at 240-250 kPa will be delivered to the patents for 80-90 minutes while sitting or lying in a hyperbaric oxygen chamber. Patients will receive treatment once every day, except week-ends, for 40 days.

Drug: Hyperbaric Oxygen

B - delayed start

NO INTERVENTION

Delayed start: Start of treatment not before 6 months of inclusion in the study. No intervention is given during the initial period.

Interventions

Hyperbaric OxygenDRUG

100% oxygen at 240-250 kPa will be delivered to the patents for 80-90 minutes while sitting or lying in a hyperbaric oxygen chamber. Patients will receive treatment once every day, except week-ends, for 40 days.

A - Immediate start

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent prior to any study specific procedures
  • Female or male aged 18-80 years
  • Intended curative radiation of the pelvic region as a treatment for cancer
  • End of radiation therapy more than 6 months ago
  • Radiation cystitis with Urological EPIC \< 80
  • Radiation cystitis is the most probable cause for the patient's symptoms

You may not qualify if:

  • Patients with major and ongoing bleedings from the bladder (requiring more than 0.5L blood-transfusion within the last four weeks)
  • Refractory incontinence requiring catheter or surgical intervention
  • Urine bladder capacity \< 100ml
  • Fistula in the urine bladder
  • Contraindications for HBOT according to the local centres routines
  • Pregnancy
  • Mechanical ventilator support
  • Unable to follow and understand simple commands
  • Not oriented to person, place and time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Rigshospitalet Copenhagen

Copenhagen, Denmark

Location

Turku Hospital

Turku, Finland

Location

Haukeland Universitetssykehus

Bergen, Norway

Location

Shalgrenska University Hospial

Gothenburg, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 40291346DERIVED

  • Oscarsson 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.

    PMID: 31537473DERIVED

MeSH Terms

Conditions

Cystitis

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Nicklas Oscarsson, MD

    Sahlgrenska, Gothenburg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 8, 2012

Study Start

August 1, 2012

Primary Completion

August 9, 2018

Study Completion

August 9, 2018

Last Updated

June 26, 2019

Record last verified: 2019-06

Locations

SE(2)DK(1)NO(1)FI(1)