Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled Trial (RICH-ART)

June 24, 2019 updated by: Göteborg University

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet Copenhagen
  • Finland
      • Turku, Finland
        • Turku hospital
  • Norway
      • Bergen, Norway
        • Haukeland Universitetssykehus
  • Sweden
      • Gothenburg, Sweden
        • Shalgrenska University Hospial
      • Stockholm, Sweden
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: A - Immediate start
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
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.
NO_INTERVENTION: B - delayed start
Delayed start: Start of treatment not before 6 months of inclusion in the study. No intervention is given during the initial period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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"

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Microscopic assessment
Time Frame: At inclusion and 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B)
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)
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)
Time Frame: At inclusion and 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B)

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)
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)
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"

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).
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
Time Frame: Every day during HBOT (8 weeks).
Adverse events (AE) are recorded during HBOT and Serious adverse events (SAE) until visit 4.
Every day during HBOT (8 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Göteborg University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sahlgrenska University Hospital, Sweden

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicklas Oscarsson, MD, Sahlgrenska, Gothenburg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 9, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 9, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RICH-ART 2012-001381-15
  • 2012-001381-15 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings