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

Phase 2/Phase 3
18 Years
80 Years
Open (Enrolling)
Cystitis, Radio Induced

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Trial Information

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

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.

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

EPIC (Expanded Prostate cancer Index Composite)

Outcome 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).

Outcome 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"

Safety Issue:


Principal Investigator

Nicklas Oscarsson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sahlgrenska, Gothenburg University


Sweden: Medical Products Agency

Study ID:

RICH-ART 2012-001381-15



Start Date:

August 2012

Completion Date:

Related Keywords:

  • Cystitis, Radio Induced
  • Radio therapy
  • STRI
  • Urinary bladder
  • Hyperbaric Oxygen
  • Cystitis