Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07883005

PHASE3

SALI-10 Probiotic to Reduce Osteoradionecrosis and Dental Toxicity Following Radiation Therapy for Head and Neck Cancer

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

Summary

This Phase III randomized controlled trial will evaluate whether long-term use of the oral probiotic Streptococcus salivarius strain SALI-10 (SALI-10) can reduce the risk of radiation-related major adverse dental events (MADE) in patients with head and neck cancer receiving definitive or postoperative radiation therapy. MADE is defined as tooth failure and/or grade 2 or higher jaw osteoradionecrosis. SALI-10 is a dual immunomodulatory and antimicrobial probiotic designed to colonize the oral cavity, promote a balanced oral microbiome, and help prevent the microbial dysbiosis and inflammation that commonly occur following radiation therapy. Participants will be randomly assigned to receive either standard of care alone or standard of care plus SALI-10 probiotic lozenges. In addition to evaluating the effect of SALI-10 on dental and jaw complications, the study will assess changes in the oral microbiome and oral inflammatory load (OIL). Diagnostic imaging and dental imaging will also be analyzed to identify potential biomarkers associated with treatment response, toxicity, and the risk of radiation-induced dental complications. The hypothesis of this study is that the long-term use of SALI-10 for HNC patients receiving definitive or post-operative RT will decrease the risk of radiation-induced major adverse dental events.

Official title: Long-term Use of Dual Immunomodulatory and Anti-microbial Probiotic (SALI-10) to Mitigate Osteoradio Necrosis and Dental Toxicity Post-radiation for Head and Neck Cancer (DIAMOND): Phase III Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

288

Start Date

2026-11-01

Completion Date

2031-11-01

Last Updated

2026-10-20

Healthy Volunteers

Conditions

Head and Neck Cancer

Interventions

OTHER

Standard of Care (SOC)

Participants will receive standard of care.

DRUG

Experimental drug

S. salivarius SALI10 probiotic lozenge

Inclusion Criteria: * Histologically confirmed malignancy of head and neck cancer patient * Patients are planned to receive definitive or postoperative RT (≥45Gy) with or without concurrent systemic therapy. * Participants must have at least one non-hopeless tooth ("hopeless" defined as non-restorable/non-salvageable and indicated for extraction) remaining or expected to remain in the mouth after completing any required pre-RT dental extractions. * Stage T1-4 N0-3 M0 (UICC/AJCC TNM 8th Edition). * Must be ≥ 18 years of age. * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Able to provide informed consent Exclusion Criteria: * Patients with history of allergy to probiotics (e.g. itchy skin, diarrhea, rhinitis). * Patients with severe immunocompromise or chronic gastrointestinal conditions that interfere with the use of probiotics * Patients who deem unable to be compliant with probiotic intake (e.g., substance abuse disorders). * Patients who are on antibiotics are not eligible except if the last dose of antibiotics was given 2 weeks prior to study registration. * Patients with head and neck cancers when target volume is far away from the jaw/teeth, such as laryngeal T1-2 N0M0 cancer planned for definitive RT with limited target volume. * Previous head and neck cancer or multiple synchronous primary head and neck cancers. * Previous RT to the head and neck region that would result in significant overlap of RT volume for the current study. * Individuals with severe, active co-morbidity including any of the following: Chronic obstructive pulmonary disease or other pulmonary illness requiring hospitalization, within 30 days of study registration, Unstable angina and/or congestive heart failure requiring hospitalization within the 30 days of study registration, Acute myocardial infarction within 30 days of study registration, Diseases precluding RT (e.g., active scleroderma, lupus or inflammatory bowel disease) \- Women who are pregnant or plan on becoming pregnant.

Locations (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada