Lactobacillus brevis CD2 lozenges reduce radiation- and chemotherapy-induced mucositis in patients with head and neck cancer: a randomized double-blind placebo-controlled study.

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.