Hyperbaric Oxygen Treatment of Chronic Refractory Radiation Proctitis: A Randomized and Controlled Double-Blind Crossover Trial With Long-Term Follow-Up

Clarke, R. W.; Tenorio, Luis Enrique David; Hussey, James R.; Toklu, Akın Savaş; Cone, D. Lindsie; Hinojosa, Jose; Desai, Samir P.; Parra, Luis Dominguez; Rodrigues, Sylvia D.; Long, Robert J.; M, Walker

doi:10.1016/j.ijrobp.2007.12.048

Cited by 207 publications

(179 citation statements)

References 37 publications

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“…Evidences: A systematic review of several case-series concluded that HBO therapy improved symptoms of radiation-induced GI toxicity in nearly 60% of patients and induced symptoms remission in 35% of patients [46] . So far, only one randomized controlled trial has been performed, comparing HBO therapy at 2.0 absolute atmospheres to normal air at 1.1 absolute atmospheres in 120 patients with chronic rectal bleeding refractory to medical treatment [47] . In this study, Clarke et al [47] found that HBO therapy significantly improved late-onset rectal bleeding, yielding a 32% absolute risk reduction and a number needed to treat equal to 3.…”

Section: Hyperbaric Oxygenmentioning

confidence: 99%

“…So far, only one randomized controlled trial has been performed, comparing HBO therapy at 2.0 absolute atmospheres to normal air at 1.1 absolute atmospheres in 120 patients with chronic rectal bleeding refractory to medical treatment [47] . In this study, Clarke et al [47] found that HBO therapy significantly improved late-onset rectal bleeding, yielding a 32% absolute risk reduction and a number needed to treat equal to 3. However, the crossover design of the trial did not allow concluding whether symptom improvement was maintained longterm in the HBO therapy arm.…”

Section: Hyperbaric Oxygenmentioning

confidence: 99%

“…HBO can be considered as a relatively safe therapy, as its reported side effects were mild, transitory and self-limiting. The most frequently reported side effects are otic barotrauma, confinement anxiety and temporary myopia [47,48] . Of note, none of these side effects led patients to stop therapy [47] .…”

Section: Hyperbaric Oxygenmentioning

confidence: 99%

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Pelvic radiation disease: Updates on treatment options

Frazzoni

Marca

Guido

et al. 2015

WJCO

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Pelvic cancers are among the most frequently diagnosed neoplasms and radiotherapy represents one of the main treatment options. The irradiation field usually encompasses healthy intestinal tissue, especially of distal large bowel, thus inducing gastrointestinal (GI) radiation-induced toxicity. Indeed, up to half of radiationtreated patients say that their quality of life is affected by GI symptoms (e.g. , rectal bleeding, diarrhoea). The constellation of GI symptoms -from transient to longterm, from mild to very severe -experienced by patients who underwent radiation treatment for a pelvic tumor have been comprised in the definition of pelvic radiation disease (PRD). A correct and evidence-based therapeutic approach of patients experiencing GI radiation-induced toxicity is mandatory. Therapeutic non-surgical strategies for PRD can be summarized in two broad categories, i.e. , medical and endoscopic. Of note, most of the studies have investigated the management of radiation-induced rectal bleeding. Patients with clinically significant bleeding (i.e. , causing chronic anemia) should firstly be considered for medical management (i.e. , sucralfate enemas, metronidazole and hyperbaric oxygen); in case of failure, endoscopic treatment should be implemented. This latter should be considered the first choice in case of acute, transfusion requiring, bleeding. More well-performed, high quality studies should be performed, especially the role of medical treatments should be better investigated as well as the comparative studies between endoscopic and hyperbaric oxygen treatments.

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Section: Hyperbaric Oxygenmentioning

confidence: 99%

Section: Hyperbaric Oxygenmentioning

confidence: 99%

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Pelvic radiation disease: Updates on treatment options

Frazzoni

Marca

Guido

et al. 2015

WJCO

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“…59,60 A recent randomized, double-blind, crossover trial demonstrated clinical improvement 3 years after therapy with an absolute risk reduction of 32% between treated and untreated patients. 61 Limitations for its wider use include the high expense and the requirement of >20 sessions to achieve noticeable results.…”

Section: 58mentioning

confidence: 99%

Late rectal complications after prostate brachytherapy for localized prostate cancer

Phan¹,

Swanson²,

Levy³

et al. 2009

Cancer

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This review of the literature on late rectal complications after prostate brachytherapy indicated that it is a highly effective treatment modality for patients with clinically localized prostate cancer but can cause chronic radiation proctitis. The most common manifestation of chronic radiation proctitis was anterior rectal wall bleeding, which often occurred within the first 2 years after brachytherapy. It is interesting to note that the rates of late rectal morbidity appear to have declined over time, which may reflect improvements in implantation techniques and imaging. Rectal biopsy as part of the workup to evaluate rectal bleeding can lead to rectal fistula and the need for colostomy, a rare but major complication. The authors recommend 1) screening colonoscopy before brachytherapy for patients who have not had a screening colonoscopy within the preceding 3 years to rule out colorectal malignancies and, thus, facilitate conservative management should rectal bleeding occur; 2) lifestyle modifications during treatment to limit exposure of the rectum to radiation; and 3) conservative management for rectal bleeding that occurs within 2 years after brachytherapy. Prostate cancer is the leading cause of cancer in men and accounts for approximately 33% of cancer deaths among men in the US.1,2 Management options for organ-confined, low-to intermediate-risk prostate cancer include watchful waiting, radical prostatectomy, external-beam radiation therapy, and prostate brachytherapy with permanent interstitial implants. Recent improvements in radioactive seed implantation techniques have established prostate brachytherapy as a highly effective treatment modality for localized prostate cancer, with long-term local and biochemical control similar to outcomes observed after radical prostatectomy and external-beam radiation therapy. 3,4 Because prostate cancer is diagnosed

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“…The pathological correlates of the response to hyperbaric oxygen in irradiated tissues have been studied in animals, and include neovascularisation with organisation and reduction in fibrous tissue [21]. Prospective randomised trials of HBO are rare, and include a study reporting benefits in radiation proctitis [22]. No serious adverse effects of HBO have been reported in any of these studies.…”

Section: Introductionmentioning

confidence: 99%

Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for cancer

Gothard

Haviland

Bryson

et al. 2010

Radiotherapy and Oncology

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a b s t r a c tBackground: A non-randomised phase II study suggested a therapeutic effect of hyperbaric oxygen (HBO) therapy on arm lymphoedema following adjuvant radiotherapy for early breast cancer, justifying further investigation in a randomised trial. Methods: Fifty-eight patients with P15% increase in arm volume after supraclavicular ± axillary radiotherapy (axillary surgery in 52/58 patients) were randomised in a 2:1 ratio to HBO (n = 38) or to best standard care (n = 20). The HBO group breathed 100% oxygen at 2.4 atmospheres absolute for 100 min on 30 occasions over 6 weeks. Primary endpoint was ipsilateral limb volume expressed as a percentage of contralateral limb volume. Secondary endpoints included fractional removal rate of radioisotopic tracer from the arm, extracellular water content, patient self-assessments and UK SF-36 Health Survey Questionnaire. Findings: Of 53/58 (91.4%) patients with baseline assessments, 46 had 12-month assessments (86.8%). Median volume of ipsilateral limb (relative to contralateral) at baseline was 133.5% (IQR 126.0-152.3%) in the control group, and 135.5% (IQR 126.5-146.0%) in the treatment group. Twelve months after baseline the median (IQR) volume of the ipsilateral limb was 131.2% .5%) in the control group and 133.5% in the treatment group. Results for the secondary endpoints were similar between randomised groups. Interpretation: No evidence has been found of a beneficial effect of HBO in the treatment of arm lymphoedema following primary surgery and adjuvant radiotherapy for early breast cancer. Ó

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Hyperbaric Oxygen Treatment of Chronic Refractory Radiation Proctitis: A Randomized and Controlled Double-Blind Crossover Trial With Long-Term Follow-Up

Cited by 207 publications

References 37 publications

Pelvic radiation disease: Updates on treatment options

Pelvic radiation disease: Updates on treatment options

Late rectal complications after prostate brachytherapy for localized prostate cancer

Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for cancer

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