AIMS AND BACKGROUND:Sixty patients with breast cancer were randomly assigned to oral glutamine or placebo pre-neoadjuvant chemotherapy (CEF regimen). METHODS AND STUDY DESIGN:Oral glutamine supplementation was continued for at least 12 days. Patients kept a daily record of diarrhea and stomatitis. The plasma glutamine level, intestinal permeability (lactulose-mannitol test), and tumor size were analyzed. The expression of Ki-67 and PCNA antigens in breast carcinoma was assessed. RESULTS: The plasma glutamine level was significantly higher in the glutamine group than in the placebo group (420.39 +/- 52.39 mmol/L vs 309.76 +/- 42.34 mmol/L, P < 0.05). After one cycle of chemotherapy, the lactulose-mannitol ratio was higher in the placebo group than in the glutamine group (0.0630 +/- 0.0091 vs 0.0471 +/- 0.0094, P < 0.05). No differences were observed in the grades of stomatitis and diarrhea, in the changes in tumor size, and in the expression of Ki-67 and PCNA antigens between the two groups. CONCLUSIONS:Prophylactic oral glutamine could ameliorate the neoadjuvant chemotherapy-induced increase in intestinal permeability, but had no significant positive clinical effect on stomatitis and diarrhea and did not interfere with the antitumor effect of chemotherapy.
RCT Entities:
AIMS AND BACKGROUND: Sixty patients with breast cancer were randomly assigned to oral glutamine or placebo pre-neoadjuvant chemotherapy (CEF regimen). METHODS AND STUDY DESIGN: Oral glutamine supplementation was continued for at least 12 days. Patients kept a daily record of diarrhea and stomatitis. The plasma glutamine level, intestinal permeability (lactulose-mannitol test), and tumor size were analyzed. The expression of Ki-67 and PCNA antigens in breast carcinoma was assessed. RESULTS: The plasma glutamine level was significantly higher in the glutamine group than in the placebo group (420.39 +/- 52.39 mmol/L vs 309.76 +/- 42.34 mmol/L, P < 0.05). After one cycle of chemotherapy, the lactulose-mannitol ratio was higher in the placebo group than in the glutamine group (0.0630 +/- 0.0091 vs 0.0471 +/- 0.0094, P < 0.05). No differences were observed in the grades of stomatitis and diarrhea, in the changes in tumor size, and in the expression of Ki-67 and PCNA antigens between the two groups. CONCLUSIONS: Prophylactic oral glutamine could ameliorate the neoadjuvant chemotherapy-induced increase in intestinal permeability, but had no significant positive clinical effect on stomatitis and diarrhea and did not interfere with the antitumor effect of chemotherapy.
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