Prevention of acute radiation-induced proctosigmoiditis by balsalazide: A randomized, double-blind, placebo controlled trial in prostate cancer patients

Jahraus, Christopher D.; Bettenhausen, Doug; Malik, Uzma; Sellitti, Marguerite; Clair, William H. St.

doi:10.1016/j.ijrobp.2005.04.032

Cited by 52 publications

(26 citation statements)

References 26 publications

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“…Sulfasalazine, 5-aminosalicylic acid (5-ASA) preparations and corticosteroid enemas have minimal or no effects on rectal tenesmus or bleeding [48] . However, recent pilot studies indicate that balsalazide, a new 5-ASA drug that yields a high concentration of active drug to the distal colon, is able to prevent or reduce symptoms of radiation-induced proctosigmoiditis [58] . In addition, irradiation-induced inflammatory response could be modulated pharmacologically based on the antiinflammatory properties of 5-ASA, which is a peroxisome proliferation-activated receptor (PPAR) activator.…”

Section: Chronic Radiation Colitis (Table 2)mentioning

confidence: 99%

Recent advances in the management of radiation colitis

Kountouras¹,

Zavos²

2008

WJG

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Section: Chronic Radiation Colitis (Table 2)mentioning

confidence: 99%

Recent advances in the management of radiation colitis

Kountouras¹,

Zavos²

2008

WJG

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“…This is the main mechanism underlying the pathophysiology of acute radiation-induced enteritis and colitis, which are a common and potentially severe complication among cancer patients treated with radiation therapy. Attempts to treat this complication with antibiotics, sucralfate, antiinflammatory drugs such as mesalazine and balsalazide, glutamine, octreotide, proteolytic enzymes, and hyperbaric oxygen have so far provided inconclusive clinical results with failure of treatment occurring in a substantial proportion of patients [1][2][3][4][5][6][7][8][9] . Furthermore, prophylactic use of sucralfate does not reduce the burden of radiationinduced bowel toxicity but rather, is associated with more severe gastrointestinal symptoms including bleeding and fecal incontinence [10,11] .…”

Section: Introductionmentioning

confidence: 99%

Use of probiotics for prevention of radiation-induced diarrhea

Delia

Sansotta²,

Donato³

et al. 2007

WJG

247

235

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AIM:To investigate the efficacy of a high-potency probiotic preparation on prevention of radiation-induced diarrhea in cancer patients. METHODS:This was a double-blind, placebo-controlled trial. Four hundred and ninety patients who underwent adjuvant postoperative radiation therapy after surgery for sigmoid, rectal, or cervical cancer were assigned to either the high-potency probiotic preparation VSL#3 (one sachet t.i.d. ,) or placebo starting from the first day of radiation therapy. Efficacy endpoints were incidence and severity of radiation-induced diarrhea, daily number of bowel movements, and the time from the start of the study to the use of loperamide as rescue medication. RESULTS:More placebo patients had radiation-induced diarrhea than VSL#3 patients (124 of 239 patients, 51.8%, and 77 of 243 patients, 31.6%; P < 0.001) and more patients given placebo suffered grade 3 or 4 diarrhea compared with VSL#3 recipients (55.4% and 1.4%, P < 0.001). Daily bowel movements were 14.7 ± 6 and 5.1 ± 3 among placebo and VSL#3 recipients (P < 0.05), and the mean time to the use of loperamide was 86 ± 6 h for placebo patients and 122 ± 8 h for VSL#3 patients (P < 0.001). CONCLUSION:Probiotic lactic acid-producing bacteria are an easy, safe, and feasible approach to protect cancer patients against the risk of radiation-induced diarrhea.

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“…Despite the treatment groups possibly stayed under stress due to daily feeding of under ether anesthesia with orogastric probe, treatments were effective to prevent significant weight loss. In a placebo-controlled balsalazid study on radiation proctitis [23], also a weight loss was observed in the placebo group, while a weight gain was observed in the group that used balsalazid.…”

Section: Discussionmentioning

confidence: 94%

The Efficacy of Probiotic (Lactobacillus rhamnosus GG) and 5-ASA (Aminosalicylic Acid) in the Treatment of Experimental Radiation Proctitis in Rats

et al. 2013

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The aims of the study are to demonstrate the effect of probiotic use on the healing of radiation proctitis (RP) and evaluate the efficiency of fecal biomarkers at follow-up of the treatment. Thirty-two male/female rats were randomly separated into four groups of eight rats. The first group (control) was not radiated. RP was created by 17.5 Gy single dose rectal irradiation. The second group (RP) was subjected to RP, but not treated. The third group (RP+ASA) was treated with 5-aminosalicylic acid (5-ASA) 250 mg/kg daily by gastric lavage for 14 days after the irradiation, and the forth group (RP+LGG) was treated with Lactobacillus GG (LGG) 25×100 million CFU daily. Feces samples were taken at the 7th and 14th day of the treatment for fecal biomarkers. Rectums of the rats were resected at the 14th day by laparotomy. Samples were evaluated both macroscopically and microscopically. RP was achieved both macroscopically and microscopically. Weight loss of RP group is statistically significant (p < 0.005) than other groups. The healing ratio of RP+ASA and RP+LGG groups was significantly better than the RP group (p<0.005) both macroscopically and microscopically. But there was no significant difference between ASA and LGG groups. Biochemically, fecal calprotectin was found to be more effective than fecal myeloperoxidase and fecal lactoferrin to show the efficacy of treatment of radiation proctitis. The results of our study demonstrate that probiotic is as effective as 5-aminosalicylic in the treatment of radiation proctitis, and fecal calprotectin is a useful biomarker in determining the response to the treatment.

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Prevention of acute radiation-induced proctosigmoiditis by balsalazide: A randomized, double-blind, placebo controlled trial in prostate cancer patients

Cited by 52 publications

References 26 publications

Recent advances in the management of radiation colitis

Recent advances in the management of radiation colitis

Use of probiotics for prevention of radiation-induced diarrhea

The Efficacy of Probiotic (Lactobacillus rhamnosus GG) and 5-ASA (Aminosalicylic Acid) in the Treatment of Experimental Radiation Proctitis in Rats

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