Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled 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. 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)

Timeline

Start

2012-08

Primary completion

2018-08-09

Completion

2018-08-09

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.
• 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.

Drugs

Indications