Hyperbaric Oxygen Treatment of Chronic Refractory Radiation Proctitis: A Randomized and Controlled Double-Blind Crossover Trial With Long-Term Follow-Up
Received 19 October 2007; received in revised form 7 December 2007; accepted 12 December 2007. published online 13 March 2008.
Purpose
Cancer patients who undergo radiotherapy remain at life-long risk of radiation-induced injury to normal tissues. We conducted a randomized, controlled, double-blind crossover trial with long-term follow-up to evaluate the effectiveness of hyperbaric oxygen for refractory radiation proctitis.
Methods and Materials
Patients with refractory radiation proctitis were randomized to hyperbaric oxygen at 2.0 atmospheres absolute (Group 1) or air at 1.1 atmospheres absolute (Group 2). The sham patients were subsequently crossed to Group 1. All patients were re-evaluated by an investigator who was unaware of the treatment allocation at 3 and 6 months and Years 1–5. The primary outcome measures were the late effects normal tissue-subjective, objective, management, analytic (SOMA-LENT) score and standardized clinical assessment. The secondary outcome was the change in quality of life.
Results
Of 226 patients assessed, 150 were entered in the study and 120 were evaluable. After the initial allocation, the mean SOMA-LENT score improved in both groups. For Group 1, the mean was lower (p = 0.0150) and the amount of improvement nearly twice as great (5.00 vs. 2.61, p = 0.0019). Similarly, Group 1 had a greater portion of responders per clinical assessment than did Group 2 (88.9% vs. 62.5%, respectively; p = 0.0009). Significance improved when the data were analyzed from an intention to treat perspective (p = 0.0006). Group 1 had a better result in the quality of life bowel bother subscale. These differences were abolished after the crossover.
Conclusion
Hyperbaric oxygen therapy significantly improved the healing responses in patients with refractory radiation proctitis, generating an absolute risk reduction of 32% (number needed to treat of 3) between the groups after the initial allocation. Other medical management requirements were discontinued, and advanced interventions were largely avoided. Enhanced bowel-specific quality of life resulted.
†Department of Radiation Oncology, Instituto Nacional de Cancerologia, Mexico City, Mexico
‡Department of Epidemiology and Biostatistics, University of South Carolina Arnold School of Public Health, Columbia, SC
§Department of Underwater and Hyperbaric Medicine, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey
¶Department of Family and Preventive Medicine, University of South Carolina School of Medicine, Columbia, SC
‖Department of Surgery, Instituto Nacional de Cancerologia, Mexico City, Mexico
#Department of Radiation Oncology, University of Pretoria Medical Centre, Pretoria, Republic of South Africa
∗∗Wesley Centre for Hyperbaric Medicine, Wesley Medical Centre, Brisbane, Australia
††Department of Diving and Hyperbaric Medicine, Royal Hobart Hospital, Tasmania, Australia
Reprint requests to: Richard E. Clarke, C.H.T., 5 Richland Medical Park, Columbia, SC 29203. Tel: (803) 434-7101; Fax: (803) 434-4354
Supported in part by grants from the Lotte and John Hecht Memorial Foundation and National Baromedical Services, and equipment from Sechrist Industries.
Presented in part at the Undersea and Hyperbaric Medical Society Annual Scientific Meeting, Sydney, Australia, May 27–30, 2004; the Hyperbaric Nurses and Technicians Association Annual Meeting, Adelaide, Australia, August 9–11, 2007; and the Undersea and Hyperbaric Medical Society Gulf Coast Chapter Annual Scientific Meeting, Nashville, Tennessee. September 1, 2007.
Conflict of interest: R. E. Clarke provides hyperbaric medicine support services; and S. D. Rodrigues was compensated for lectures by Roche in 2007 and sat on the pain management board of Jansen Cilag in 2006.
ABSTRACT