30 september 2019: Bron: The Lancet

Wanneer mensen bestraald worden in het bekkengebied dan krijgen veel patienten vaak na een half jaar tot anderhalf jaar later last van blaasontstekingen (cystitis) die soms echt ernstig, pijnlijk en vaak ook chronisch kunnen zijn. Uit een studie met totaal 87 patienten (42 vs 45) blijkt dat als bij patienten na de bestraling van het bekkengebied blaasontstekingen ontstaan kunnen een aantal sessies met hyperbare zuurstof (30 tot 40 keer) deze laat optredende blaasontstekingen worden genezen en verder voorkomen. Niet in alle gevallen maar in ieder geval veel beter dan standaard zorg voor deze bijwerkingen van bestraling.

Zelf heb ik ook goede ervaringen met hyperbare zuurstoftherapie toen mijn kiezen moesten worden getrokken in bestraald gebied.

Dit blijkt uit een gerandomisseerde studie gepubliceerd in the Lancet: Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2–3 trial

Patiënten met late door bestraling veroorzaakte blaasontstekingen (cystitis) na radiotherapie van het bekkengebied werden gerandomiseerd ingedeeld om hyperbare zuurstoftherapie of standaardzorg te ontvangen in deze fase II / III-studie. Hyperbare zuurstoftherapie is in verband gebracht met een significante vermindering van de incidentie van chronische pijn en is veilig en wordt goed verdragen.
Hyperbare zuurstoftherapie lijkt sommige symptomen van late bestralingsontstekingen te verlichten en is een veilige behandelingsoptie.
Hier het abstract van de studie die voor zichzelf spreekt neem ik aan:

Correction: Oscarsson N, Müller B, Rosén A, et al. Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2–3 trial. Lancet Oncol 2019; published online Sept 16. https://doi.org/10.1016/S1470-2045(19)30494-2—In the summary of this Article, the first sentence of the Findings section should have read “Of 223 patients screened between May 9, 2012, and Dec 20, 2017, 87 patients were enrolled and randomly assigned to either hyperbaric oxygen therapy (n=42) or standard care (n=45).” This correction has been made to the online version as of September 23, 2019, and will be made to the printed version.

Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2–3 trial

Published:September 16, 2019DOI:https://doi.org/10.1016/S1470-2045(19)30494-2

Summary

Background

Late radiation cystitis is an adverse effect of cancer treatment with radiotherapy in the pelvic region. Symptoms of late radiation cystitis can be assessed with the Expanded Prostate Index Composite Score (EPIC). Previous reports indicate that hyperbaric oxygen therapy reduces symptoms from late radiation cystitis, but the evidence is predominantly based on non-randomised and retrospective studies. We aimed to assess whether hyperbaric oxygen therapy would mitigate symptoms of late radiation cystitis.

Methods

We did a randomised, controlled, phase 2–3 trial (RICH-ART [Radiation Induced Cystitis treated with Hyperbaric oxygen—A Randomised controlled Trial]) at five Nordic university hospitals. All patients aged 18–80 years, with pelvic radiotherapy completed at least 6 months previously, a score of less than 80 in the urinary domain of the Expanded Prostate Index Composite Score (EPIC), and referred to participating hyperbaric clinics due to symptoms of late radiation cystitis, were eligible for inclusion. Exclusion criteria were ongoing bleeding requiring blood transfusion exceeding 500 mL in the past 4 weeks, permanent urinary catheter, bladder capacity less than 100 mL, fistula in the urinary bladder, previous treatment with hyperbaric oxygen therapy for late radiation injuries, and contraindications to hyperbaric oxygen therapy. After computer-generated 1:1 randomisation with block sizes of four for each stratification group (sex, time from radiotherapy to inclusion, and previous invasive surgery in the pelvic area), patients received hyperbaric oxygen therapy (30–40 sessions, 100% oxygen, breathed at a pressure of 240–250 kPa, for 80–90 min daily) or standard care with no restrictions for other medications or interventions. No masking was applied. The primary outcome was change in patient-perceived urinary symptoms assessed with EPIC from inclusion to follow-up at visit 4 (6–8 months later), measured as absolute change in EPIC urinary total score. RICH-ART closed enrolment on Dec 31, 2017; the last follow-up data will be compiled in 2023. RICH-ART is registered with ClinicalTrials.gov, number NCT01659723, and with the European Medicines Agency, number EudraCT 2012-001381-15.

Findings

Of 223 patients screened between May 9, 2012, and Dec 20, 2017, 87 patients were enrolled and randomly assigned to either hyperbaric oxygen therapy (n=42) or standard care (n=45). After excluding eight patients who withdrew consent directly after randomisation (one in the hyperbaric oxygen therapy group and seven in the standard care group), 79 were included in the intention-to-treat analyses (n=41 in the hyperbaric oxygen therapy group, n=38 in the standard care group). Median time from randomisation to visit 4 was 234 days (IQR 210–262) in the hyperbaric oxygen therapy group and 217 days (195–237) in the standard care group. The difference between change in group mean of EPIC urinary total score at visit 4 was 10·1 points (95% CI 2·2–18·1; p=0·013; 17·8 points [SD 18·4] in the hyperbaric oxygen therapy group vs 7·7 points [15·5] in the standard care group). 17 (41%) of 41 patients in the hyperbaric oxygen therapy group experienced transient grade 1–2 adverse events, related to sight and hearing, during the period of hyperbaric oxygen therapy.

Interpretation

Our results suggest that hyperbaric oxygen therapy relieves symptoms of late radiation cystitis. We conclude that hyperbaric oxygen therapy is a safe and well tolerated treatment.

Funding

The regional research fund of Region Västra Götaland, Sweden, the regional Health Technology Assessment Centre at Sahlgrenska University Hospital, Sweden, and Lions Cancer Research Fund of Western Sweden.