Hyperbaric oxygen therapy safe, effective for treating symptoms of late radiation cystitis
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Hyperbaric oxygen therapy safely relieved symptoms of late radiation cystitis among patients who received radiotherapy for cancer in the pelvic region, according to results of the randomized phase 2/phase 3 RICH-ART trial published in The Lancet Oncology.
“This treatment is highly effective for the majority of patients,” Nicklas Oscarsson, doctoral student in anesthesiology and intensive care at University of Gothenburg in Sweden, said in a press release. “It’s a great pleasure to hear patients tell us how they feel they’re returning to a normal human life. This also applies to those who get better but perhaps aren’t entirely well.”
Late radiation cystitis, a chronic and progressive condition, occurs in 5% to 15% of patients who underwent radiotherapy to the pelvic area for diseases such as prostate, rectal or gynecologic cancers. Symptoms can develop years after radiotherapy and include hematuria, increased urge to urinate, incontinence and dysuria. Treatment for the condition usually includes a combination of anticholinergic drugs and training of pelvic floor muscles. Serious cases often require hospital care.
Another treatment option employed in some countries to alleviate symptoms is hyperbaric oxygen therapy, although evidence of its efficacy has been based largely on nonrandomized and retrospective studies.
Oscarsson and colleagues sought to expand on the evidence by randomly assigning 79 adults who underwent curative-intent radiotherapy of the pelvic region at least 6 months earlier and experienced symptoms of late radiation cystitis to hyperbaric oxygen therapy (n = 41) or standard treatment (n = 38).
Forty-four patients had prostate cancer, 18 had cervical cancer, three had rectal cancer, two had cancer of the uterus and two had unspecified cancer.
Patients in the hyperbaric oxygen therapy group underwent between 30 and 40 sessions of 100% oxygen treatment, breathed at a pressure of 240 kPa to 250 kPa for 80 to 90 minutes daily. Patients in the control group received standard care, which typically includes physical therapy or medication, without restrictions for other treatments.
Change in patient-perceived urinary symptoms, assessed with the Expanded Prostate Index Composite (EPIC) score and calculated as absolute change in EPIC urinary total score from randomization to the fourth visit 6 to 8 months later, served as the study’s primary endpoint.
Median time from randomization to the fourth visit was 234 days (interquartile range [IQR], 210-262) for the hyperbaric oxygen therapy group and 217 days (IQR, 195-237) for the control group.
Results showed a mean EPIC urinary total score increase of 17.8 points (standard deviation [SD], 18.4) in the hyperbaric oxygen therapy group vs. a 7.7-point increase (SD, 15.5) in the standard therapy group, for a difference of 10.1 points (95% CI, 2.2-18.1; P = .013).
Hyperbaric oxygen therapy appeared generally well-tolerated, with 17 patients experiencing grade 1 or grade 2 adverse events. These included ear pain, myopia and barotrauma. One patient in the standard therapy group died of heart failure.
Although the study supports hyperbaric oxygen therapy for delayed radiation cystitis, the optimal course of therapy still needs to be determined, John J. Feldmeier, DO, FARCO, FUHM, professor and co-director of the Urology Cancer Clinic at University of Toledo Medical Center, wrote in an accompanying editorial.
“[I] advise against anything fewer than 40 treatments, pressures less than 2.4 atmospheres absolute (approximately 240 kPa), and time on 100% oxygen less than 90 minutes,” Feldmeier wrote.
“Long-term follow-up in patients from this study will be essential to establish the durability of response to hyperbaric treatment and the need for additional treatments,” he noted. “It is important to remember that the other so-called standard treatments are subject to disease recurrence and often need to be repeated. The only true definitive treatment for this group is cystectomy and urinary diversion, [which results] in a substantial deterioration in quality of life.”– by John DeRosier
Disclosures: Oscarsson reports research funding from Health Technology Assessment Centre at Sahlgrenska University in Sweden, Lions Cancer Research Fund of Western Sweden and Regional Research Fund VGR, and serving as a board member for MediCase AB. Please see the study for all other authors’ relevant financial disclosures. Feldmeier report no relevant financial disclosures.
Perspective
Back to TopCarolina E. Fasola, MD, MPH
This phase 2/phase 3 trial adds some much-needed prospective randomized data to the current literature for hyperbaric oxygen, which had largely consisted of retrospective studies.
Treatment of late radiation cystitis can be challenging. Although most urinary complications are managed successfully with conservative supportive treatment, patients with severe complications may require invasive treatment, including cystectomy and urinary diversion for refractory cases.
This study demonstrated a small but significant benefit with hyperbaric oxygen compared with standard supportive treatment. The typical hyperbaric oxygen regimen — as described in the paper — requires 30 to 40 sessions at 80 to 90 minutes per session. Hyperbaric oxygen remains a good option to consider for patients experiencing high-grade radiation cystitis and appears to be well-tolerated, but the time commitment may be prohibitive for certain patients.
Fortunately, late toxicity with radiation cystitis has become a rare complication in the era of technological advances in treatment delivery. Such advances, including increasing use of intensity-modulated radiation therapy, have significantly reduced the risk for radiation cystitis.
For instance, also using EPIC as an instrument for patient-reported urinary toxicity, researchers of the NRG Oncology-RTOG 1203 trial — a phase 3 randomized trial of patients with endometrial or cervical cancer who received postoperative pelvic radiation or chemoradiation, and were randomly assigned to conventional four-field or IMRT pelvic radiation treatment — found that at 3 years after radiation, there was a statistically significant increase in urinary toxicity reported among patients who received four-field pelvic radiation vs. IMRT.
With the increased use of IMRT to treat prostate cancer, lower rates of late radiation cystitis are being reported, as well. We hope to continue to minimize the risks for late toxicity with radiation cystitis for patients who require pelvic radiation in the future.
However, in the event of high-grade radiation cystitis causing debilitating quality-of-life consequences, this study provides support for a referral for hyperbaric oxygen in order to help mitigate those symptoms.
Reference:
Yeung AR, et al. Abstract 101. Presented at: ASTRO Annual Meeting; Sept. 15-18, 2019; Chicago.
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Feldmeier JJ. Lancet Oncol. 2019;doi:10.1016/S1470-2045(19)30574-1.
Oscarsson N, et al. Lancet Oncol. 2019;doi:10.1016/S1470-2045(19)30494-2.
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