Clarke RE, Tenorio LM, Hussey JR, Toklu AS, Cone DL, Hinojosa JG, Desai SP, Dominguez Parra L, Rodrigues SD, Long RJ, Walker MB, et al.
International journal of radiation oncology, biology, physics. Date of publication 2008 Sep 1;volume 72(1):134-143.
1. Int J Radiat Oncol Biol Phys. 2008 Sep 1;72(1):134-143. doi:
10.1016/j.ijrobp.2007.12.048. Epub 2008 Mar 14.
Hyperbaric oxygen treatment of chronic refractory radiation proctitis: a
randomized and controlled double-blind crossover trial with long-term follow-up.
Clarke RE(1), Tenorio LM, Hussey JR, Toklu AS, Cone DL, Hinojosa JG, Desai SP,
Dominguez Parra L, Rodrigues SD, Long RJ, Walker MB.
Author information:
(1)Baromedical Research Foundation, Columbia, SC 29203, USA.
dick.clarke@palmettohealth.org
Comment in
Int J Radiat Oncol Biol Phys. 2008 Dec 1;72(5):1621; author reply 1621.
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.
DOI: 10.1016/j.ijrobp.2007.12.048
PMID: 18342453 [Indexed for MEDLINE]
