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Cystitis, Radio InducedPhase 2/3RICH-ARTNCT01659723

Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled Trial

A Phase 2/3 study testing Hyperbaric Oxygen in people with Cystitis, Radio Induced, run by Göteborg University at 5 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cystitis, Radio Induced
What is being tested?
Hyperbaric Oxygen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
5 sitesin 4 countries
Study dates
Aug 2012to 9 Aug 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • Mechanical ventilator support
  • Unable to follow and understand simple commands
  • Not oriented to person, place and time

Trial locations and contacts

5 sites in 4 countries.

5 sites in 4 countries

Sweden2 sites

  • Shalgrenska University Hospial

    Gothenburg

  • Karolinska University Hospital

    Stockholm

Other trials in Sweden

Denmark1 site

  • Rigshospitalet Copenhagen

    Copenhagen

Other trials in Denmark

Finland1 site

  • Turku Hospital

    Turku

Other trials in Finland

Norway1 site

  • Haukeland Universitetssykehus

    Bergen

Other trials in Norway

About this study

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)
Read the detailed description

Radiotherapy is commonly used in the management of malignant diseases. Despite a continuous improvement of the technique, with improved efficacy and tolerance, adverse effects are still rather common. The urinary bladder and rectum are the major organs most commonly affected by radiotherapy to the pelvis area.

One of the most significant causes of the symptoms of radio therapy is inflammation and degeneration of blood vessels in the radiated tissue. Hyperbaric oxygen therapy involves administration of oxygen at greater than normal atmospheric pressures. A well-documented effect of HBOT is the stimulation of angiogenesis. HBOT is an established treatment for degeneration of blood vessels in the jaw bone as a result of radiotherapy and several publications have shown good efficacy also when soft tissue is affected.

If the method of treatment with HBOT means a reduction of the radiotherapy side effect it is thus an obvious importance for the individual patient. There is also significant potential savings for the healthcare and society.

Being tested
Hyperbaric Oxygen
Keywords
Radio therapy, STRI, Urinary bladder, Hyperbaric Oxygen
Medical subject headings
Cystitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT01659723
Study groupRoleWhat they receive
A - Immediate startActive comparatorStart 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.
Receives: Drug: Hyperbaric Oxygen
B - delayed startNo interventionDelayed start: Start of treatment not before 6 months of inclusion in the study. No intervention is given during the initial period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

  1. Microscopic assessment

    To investigate the mucosa with respect to functionality by assessment of inflammation activity, quantification of fibrosis, vascular density and the presence of stems cells having histological analysis from biopsies as variable. Comparison will be made between group A (post treatment) and group B (pre treatment)

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

  2. RTOG (Radiation Toxicity Grade by Radiation Therapy Oncology Group)

    RTOG is an internationally well established research group in the oncology field. They have developed organ specific scales for quantification of both acute and late symptoms after radiation. The scale range is from 0 to 5, where 0 is used for normal function and findings and 5 for death directly related to injuries post radiation. Both subjective and objective findings are used when setting the score.

    Comparison will be made between Group A (post treatment) and Group B (pre treatment)

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

  3. SF-36 (Short Form Health Survey 36)

    SF-36 is a self-administered questionnaire and contains 36 items which measure eight dimensions and assess health-related quality of life. 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).

    Measured: 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"

  4. Adverse events

    Adverse events (AE) are recorded during HBOT and Serious adverse events (SAE) until visit 4.

    Measured: Every day during HBOT (8 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completion9 Aug 2018
  4. Study completion9 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01659723
Sponsor's protocol ID
RICH-ART 2012-001381-15
Other IDs
2012-001381-15
Acronym
RICH-ART
Status last verified
Jun 2019
First submitted
2 Aug 2012
Last updated
26 Jun 2019
Results posted
No
Data monitoring committee
Yes

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 40291346

  • 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.

    PubMed 31537473

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Hyperbaric Oxygen in people with Cystitis, Radio Induced, run by Göteborg University at 5 sites in 4 countries.

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 6 inclusion and 9 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: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Sweden, Denmark, Finland, Norway. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EPIC (Expanded Prostate cancer Index Composite) (time frame: 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"). 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 NCT01659723, 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 26 Jun 2019; AzTrials last refreshed its copy on 27 Oct 2026.

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