Clinical trial NCT05707702: Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia
Official title: Lactobacillus Lozenges as Preventative Care in Low-grade Dysplasia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Low-grade Oral Dysplasia
Keywords: Probiotic lozenge
Oral cavity squamous cell carcinoma
Oral microbiome
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2023-02-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There are limited evidence-based management options for patients with low-grade oral dysplasia. Despite the risk of malignant transformation, management is frequently limited to risk factor reduction (such as smoking cessation) and clinical surveillance. An intervention for low-grade oral dysplasia which could induce regression or decrease rates of malignant transformation has the potential to be a valuable preventative tool to reduce rates of oral cancer.

The investigators will conduct a randomized clinical trial to investigate if the administration of a probiotic lozenge to patients with low-grade oral dysplasia result in decreased peri-tumoral inflammation as evidenced by impacts on populations of tumor-associated macrophages and tumor-infiltrating lymphocytes, and decreased dysbiosis at the disease site compared with the contralateral normal site. The investigators hypothesize that these changes may increase the rate of clinical regression of these lesions.


Eligibility criteria: Inclusion Criteria:

* Presence of biopsy-proven low-grade or mild oral dysplasia

Exclusion Criteria:

* Active oral cavity malignancy
* Active oral cavity high grade dysplasia
* Currently undergoing chemotherapy or immunotherapy, or have used these agents within the prior 6 months
* History of external beam radiation therapy to the head and neck area
* Diagnosis of HIV with decreased CD4 count and/or detectable viral load
* Current use of systemic or orally absorbed steroids
* Patient undergoing stem cell transplantation
* Patients taking anti-rejection medication after stem cell or solid organ transplantation
* Patients using injectable immunosuppressive drugs for autoimmune disease
* Pregnant or nursing women
* Patients who are hospitalized
* Patients with a heart valve abnormalities or a history of valve replacement or endocarditis
* Patients with active severe acute intestinal disease (active bowel leak, acute abdomen, active colitis) or a history of short bowel syndrome

Primary outcomes:
measure: Clinical regression of dysplastic lesion
timeFrame: 6 weeks
Secondary outcomes:
measure: Microbiome at the lesion site
timeFrame: baseline, 6 weeks, 12 weeks
measure: Change in peri-tumoral inflammation
timeFrame: baseline, 6 weeks
measure: Oral dysplasia lesions at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Otolaryngology
name: Heather Edwards, MD
role: PRINCIPAL_INVESTIGATOR
References: