A Phase III, Randomized, Double-Blind Study of Lactobacillus Brevis CD2 Lozenges Versus Placebo in the Prevention of Acute Oral Mucositis (OM) in Patients With Head and Neck Cancer Receiving Concurrent Radiotherapy and Chemotherapy
- To determine whether Lactobacillus brevis CD2 lozenges are effective in reducing oral
mucositis (OM)-related pain in patients undergoing chemoradiotherapy (CRT) for head and
neck squamous cell carcinoma, as measured by the area under the curve (AUC) of Mouth
and Throat Soreness (MTS) score (Oral Mucositis Daily Questionnaire [OMDQ] question 2)
measured daily during CRT and daily for 4 weeks after completion of CRT.
- To assess whether L. brevis CD2 lozenges reduce OM as assessed by the provider using
the WHO OM scale, Oral Mucositis Assessment Scale (OMAS), and Common Terminology
Criteria Adverse Events (CTCAE).
- To assess whether L. brevis CD2 lozenges reduce the impact of OM on the ability to
swallow, drink, eat, talk, and sleep, as assessed by the MTS-Activity Limitations
- To assess whether L. brevis CD2 lozenges improve quality of life, as assessed by the
Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN).
- To assess whether L. brevis CD2 lozenges reduce opioid requirements.
- To assess whether L. brevis CD2 lozenges improve radiotherapy compliance.
- To assess whether L. brevis CD2 lozenges reduce weight loss and the need for a feeding
- To assess whether L. brevis CD2 lozenges affect disease-free survival (DFS) at 12
months after treatment.
- To evaluate the effect of L. brevis CD2 lozenges on salivary biomarkers, including
metabonomic and inflammatory markers, as measured at baseline, week 3 of CRT, and
during the last week of CRT. (exploratory)
OUTLINE: This is a multicenter, randomized, placebo-controlled, double-blind study. Patients
are stratified according to primary disease site (oral cavity/oropharynx vs nasopharynx vs
hypopharynx/larynx), context of chemoradiotherapy (CRT) (definitive vs post-operative),
cisplatin schedule (every 3 weeks [100 mg/m^2] vs every week [30-40 mg/m^2]), and use of
intensity-modulated radiotherapy (IMRT) (yes vs no). Patients are randomized to 1 of 2
- Arm I: Patients dissolve in mouth 1 lozenge of Lactobacillus brevis CD2 every 2-3 hours
(total of 6 per day) daily during CRT (comprising cisplatin and radiotherapy [RT]) and
for 4 weeks after, including weekends.
- Arm II: Patients dissolve in mouth 1 lozenge of placebo every 2-3 hours (total of 6 per
day) daily during CRT and for 4 weeks after, including weekends.
Patients complete questionnaires about their quality of life and pain at baseline and daily
during study treatment.
Saliva is collected from some patients before starting RT, during week 3 of RT, and during
the last week of RT for NMR-spectroscopic metabolomic analysis and future cytokine analysis.
After completion of study treatment, patients are followed up at 12 months.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
The AUC of the MTS score
Robert C. Miller, MD