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

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.

• Authors: Atul Sharma, G K Rath, S P Chaudhary, Alok Thakar, Bidhu Kalyan Mohanti, Sudhir Bahadur
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 48 Issue 6 Pg. 875-81 (Apr 2012) ISSN: 1879-0852 [Electronic] England
• PMID: 21741230 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2011 Elsevier Ltd. All rights reserved.

Topics

• Administration, Oral
• Adult
• Aged
• Carcinoma, Squamous Cell (therapy)
• Chemoradiotherapy (adverse effects)
• Double-Blind Method
• Female
• Head and Neck Neoplasms (therapy)
• Humans
• Incidence
• India (epidemiology)
• Levilactobacillus brevis
• Male
• Middle Aged
• Mouth Mucosa (drug effects, radiation effects)
• Stomatitis (epidemiology, etiology, prevention & control)
• Survival Analysis