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  • Title: Lactobacillus brevis CD2 lozenges reduce radiation- and chemotherapy-induced mucositis in patients with head and neck cancer: a randomized double-blind placebo-controlled study.
    Author: Sharma A, Rath GK, Chaudhary SP, Thakar A, Mohanti BK, Bahadur S.
    Journal: Eur J Cancer; 2012 Apr; 48(6):875-81. PubMed ID: 21741230.
    Abstract:
    BACKGROUND: Oral mucositis is a frequent and serious complication in patients receiving chemo-radiotherapy for head and neck squamous cell carcinoma. This study evaluated the effects of administering Lactobacillus brevis CD2 lozenges on the incidence and severity of mucositis and tolerance to chemo-radiotherapy. METHODS: Two hundred patients suitable for chemo-radiotherapy were enrolled in a randomised, double-blind study to receive daily treatment with lozenges containing either L. brevis CD2 or placebo. Anticancer therapy was RT 70 Grays/35 fractions over 7 weeks with weekly Inj. Cisplatin 40 mg/m(2). The study treatment was given during, and for 1 week after completion of anticancer therapy. Primary end-points were the incidence of grade III and IV oral mucositis and the percentage of patients able to complete anticancer treatment. FINDINGS: The efficacy analysis included the 188 patients who received ≥ 1 week of study treatment. Grade III and IV mucositis developed in 52% of patients in the L. brevis CD2 arm and 77% in the placebo arm (P<0.001). Anticancer treatment completion rates were 92% in the L. brevis CD2 arm and 70% in the placebo arm (P=0.001). A larger proportion of patients remained free of mucositis when treated with L. brevis CD2 (28%) compared to the placebo (7%). INTERPRETATION: L. brevis CD2 lozenges reduced the incidence of grade III and IV anticancer therapy-induced oral mucositis and were associated with a lower overall rate of mucositis and a higher rate of anticancer treatment completion.
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