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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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"
Nicklas Oscarsson, MD
Sahlgrenska, Gothenburg University
Sweden: Medical Products Agency