Lactobacillus Lozenges

To determine the effectiveness of Lactobacillus brevis CD2 lozenges on the incidence and severity of mucositis and tolerance to chemotherapy and radiotherapy

Patients with head and neck squamous cell carcinoma (HNSCC), stages II–IVA, who were receiving chemotherapy and radiation over a seven-week period, received daily treatment with lozenges containing either L. brevis DC2 or placebo. They were required to complete at least 30 out of the planned 35 fractions of radiation treatments and at least 6 of the cisplatin chemotherapy doses. L. brevis CD2 dosing was six lozenges daily, one lozenge every 2–3 hours, dissolved first in the mouth, then swallowed.  Patients were to avoid hot beverages for at least 30 minutes before and after each treatment, to avoid affecting the efficacy of the lozenges. Placebo and active treatments were started the first day of chemotherapy and radiation therapy and continued for one week after the final treatment.

• The sample consisted of 188 patients with a mean age of 52 years old.
• The sample was 93% male and 7% female.
• Patients had been diagnosed with stage II–IVA (resectable) HNSCC.
• Patients had normal bone marrow and normal renal and hepatic function.

The study was conducted at a the Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, in New Delhi, India.

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for head and neck cancer and the male population.

This was a randomized, double-blind, placebo controlled trial.

• Observation of oral mucosa using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0 mucositis grading assessment was conducted each week by the same observer.       
• Observation of the oral cavity was conducted using photographs at each visit.
• Saliva samples were tested at the start and completion of treatment to determine levels of proinflammatory cytokines, antibodies, and metalloproteinases.
• The Functional Assessment of Cancer Therapy (FACT) Head and Neck Questionnaire Version 4 was used to assess quality of life.
   

• The overall incidence of oral mucositis was significantly decreased in the L. brevis group versus the placebo group (p < 0.001). This is based on combined findings of those remaining free of mucositis (28% in the L. brevis group versus 7% in the placebo), grades I and II mucositis (similar in both groups), and grades III and IV (52% for L. brevis arm and 77% for the placebo).
• A greater percentage of patients in the L. brevis arm completed chemotherapy and radiation treatment (92%) versus the placebo arm (70%).
• Other important results obtained included less use of analgesics to control mucositis-associated pain (30% in the L. brevis arm versus 45% in placebo).
• No significant differences in survival, quality of life, or median time to onset of mucositis was found.

Probiotic L. brevis CD2 lozenges can reduce the incidence and severity of oral mucositis in the studied patient population, allowing the patients to complete the intended course of anticancer treatment. 

The study is limited by the lack of the ability to generalize the results to other groups such as women, teenagers, or those undergoing chemotherapy alone.

• The study is effective in the specific population observed. However, the ability to apply this information to other populations, such as women, children, or other types of cancers that affect the head and neck less significantly, is limited.
• To be able to recommend this intervention, it would also help to know the expected cost of and availability or access to the lozenges.
• No adverse events related directly to the intervention were found, so use of the L. brevis CD2 lozenges in the population studied could be a very effective and important option for oncology nurses to educate the healthcare team and patients.
• The nursing implications are that a thorough understanding of the physiological consequences (lack of nutrition, pain) of uncontrolled mucositis can interrupt the treatment plan. Mucositis is painful and may result in dose reductions, treatment delays, or treatment discontinuation, so it is important to be current on the most reliable interventions.