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  • Title: Protection against chemotherapy induced mucositis by TGF-beta(2) in childhood cancer patients: results from a randomized cross-over study.
    Author: de Koning BA, Philipsen-Geerling B, Hoijer M, Hählen K, Büller HA, Pieters R.
    Journal: Pediatr Blood Cancer; 2007 May; 48(5):532-9. PubMed ID: 16767731.
    Abstract:
    BACKGROUND: Mucositis is one of the most frequent and severe side-effect of chemotherapy in childhood-cancer patients for which there is no prophylaxis available. The efficacy and feasibility of a TGF-beta(2)-enriched feeding for preventing oral and gastro-intestinal-mucositis in childhood-cancer patients were studied. PROCEDURE: The study was designed as a two-period cross-over, randomized, double-blinded, placebo, controlled trial. Patients who had a high risk for developing mucositis and who would receive two comparable cycles of chemotherapy were eligible for the study. During one cycle of chemotherapy, TGF-beta(2)-enriched feeding was administered; during the other, a "placebo" (not enriched) feeding was used. WHO toxicity scales of diarrhea, oral mucositis, fever, anal lesions and nausea/vomiting were scored daily. In addition, the incidence of occurrence of blood cultures, antibiotic therapy, and interventions or diagnostics related to mucositis were measured. RESULTS: The feasibility of the study was good: 83% of the patients completed two cycles and 86% of the study-feeding was effectively consumed. Administration of TGF-beta(2) was safe as serum TGF-beta(2) did not increase, and renal and liver function were not affected during TGF-beta(2) consumption compared to normal feeding. Differences in toxicity, scored during the whole observation period and the number of days with WHO 3/4 toxicity, were not significantly different between cycles with TGF-beta(2) enriched and normal feeding. CONCLUSIONS: TGF-beta(2) administration via feeding is well tolerated and safe. Although this study might have had limitations to show potential benefit of TGF-beta(2), it does not provide evidence that TGF-beta(2) decreases the incidence or degree of mucositis induced by combination chemotherapy in childhood-cancer patients.
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