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
18 Years
N/A
Both
Head and Neck Cancer, Oral Complications of Radiation Therapy, Pain, Weight Changes
Trial Information
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
OBJECTIVES:
Primary
- 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.
Secondary
- 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
(MTS-AL).
- 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
tube.
- 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
treatment regimens.
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologic proof of squamous cell carcinoma of the oral cavity, oropharynx,
nasopharynx, hypopharynx, or larynx
- Planned course of definitive or post-operative radiotherapy (RT) to a total dose of ≥
60 Gy using 1.8 to 2.0 Gy per fraction
- At least one third of the oral cavity mucosa must be included in the RT fields, as
estimated by the treating radiation oncologist
- Planned concurrent administration of cisplatin chemotherapy (either 100 mg/m^2 every
3 weeks or 30-40 mg/m^2 every week)
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0, 1, or 2
- Hemoglobin ≥ 10.0 g/dL
- White blood cell (WBC) ≥ 3,500 x10^9/L
- Absolute neutrophil count (ANC) ≥ 1,500 x10^9/L
- Platelet count ≥ 100,000 x10^9/L
- Willing to abstain from ingestion of yogurt products and/or any product containing
probiotics during study drug treatment
- Ability to complete questionnaire(s) by themselves or with assistance
- Willing to provide saliva samples for correlative research purposes (first 50
patients)
- Not pregnant or nursing
- Negative pregnancy test done ≤ 7 days prior to registration, for women of
childbearing potential
- Men or women of childbearing potential must employ adequate contraception
- No co-morbid systemic illnesses or other severe concurrent disease which, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens
- No current untreated oral candidiasis, oral herpes simplex virus (HSV) infection, or
oral mucositis
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No split-course RT planned
- No prior head and neck RT
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
The AUC of the MTS score
Safety Issue:
No
Principal Investigator
Robert C. Miller, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
Unspecified
Study ID:
CDR0000727295
NCT ID:
NCT01545687
Start Date:
April 2012
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Oral Complications of Radiation Therapy
- Pain
- Weight Changes
- pain
- oral complications of radiation therapy
- weight changes
- recurrent squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the oropharynx
- recurrent verrucous carcinoma of the larynx
- stage I squamous cell carcinoma of the hypopharynx
- stage I squamous cell carcinoma of the larynx
- stage I squamous cell carcinoma of the nasopharynx
- stage I squamous cell carcinoma of the oropharynx
- stage I verrucous carcinoma of the larynx
- stage II squamous cell carcinoma of the hypopharynx
- stage II squamous cell carcinoma of the larynx
- stage II squamous cell carcinoma of the nasopharynx
- stage II squamous cell carcinoma of the oropharynx
- stage II verrucous carcinoma of the larynx
- stage III squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage III squamous cell carcinoma of the nasopharynx
- stage III squamous cell carcinoma of the oropharynx
- stage III verrucous carcinoma of the larynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the nasopharynx
- stage IVA squamous cell carcinoma of the larynx
- stage IVA squamous cell carcinoma of the oropharynx
- stage IVA verrucous carcinoma of the larynx
- stage IVB squamous cell carcinoma of the larynx
- stage IVB squamous cell carcinoma of the oropharynx
- stage IVB verrucous carcinoma of the larynx
- stage IVC squamous cell carcinoma of the larynx
- stage IVC squamous cell carcinoma of the oropharynx
- stage IVC verrucous carcinoma of the larynx
- stage I squamous cell carcinoma of the lip and oral cavity
- stage I verrucous carcinoma of the oral cavity
- stage II squamous cell carcinoma of the lip and oral cavity
- stage II verrucous carcinoma of the oral cavity
- stage III squamous cell carcinoma of the lip and oral cavity
- stage III verrucous carcinoma of the oral cavity
- stage IVA squamous cell carcinoma of the lip and oral cavity
- stage IVA verrucous carcinoma of the oral cavity
- stage IVB squamous cell carcinoma of the lip and oral cavity
- stage IVB verrucous carcinoma of the oral cavity
- stage IVC squamous cell carcinoma of the lip and oral cavity
- stage IVC verrucous carcinoma of the oral cavity
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent verrucous carcinoma of the oral cavity
- Body Weight Changes
- Head and Neck Neoplasms
- Stomatitis
- Mucositis
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