Cystitis, Radio Induced Clinical Trial
Official title:
Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled Trial
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)
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.
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