Lactobacillus brevis CD2 lozenges reduce radiation- and chemotherapy-induced mucositis in patients with head and neck cancer: a randomized double-blind placebo-controlled study.
- 2012-04
- European Journal of Cancer 48(6)
- Atul Sharma
- G. Rath
- S. Chaudhary
- A. Thakar
- B. Mohanti
- S. Bahadur
- PubMed: 21741230
- DOI: 10.1016/j.ejca.2011.06.010
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.
Research Insights
Supplement | Health Outcome | Effect Type | Effect Size |
---|---|---|---|
Lactobacillus brevis | Increased Anticancer Treatment Adherence | Beneficial | Large |
Lactobacillus brevis | Reduced Mucositis | Beneficial | Moderate |