A Phase 3 interventional study of Standard of Care (SOC) and Experimental drug in Head and Neck Cancer, sponsored by University Health Network, Toronto. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by University Health Network, Toronto · Phase 3, Interventional, and Supportive care
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.
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's planned enrollment of 288 is above the median of 47 across 1,791 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University Health Network, Toronto is the lead sponsor of 1,432 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Exclusion Criteria:
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.
Standard Of Care
Other: Standard of Care (SOC)
Other: Standard of Care (SOC) · Drug: Experimental drug
Participants will receive standard of care.
S. salivarius SALI10 probiotic lozenge
Incidence of Major Adverse Dental Events (MADE)
Major adverse dental events (MADE), defined as tooth failure and/or grade 2 or higher jaw osteoradionecrosis (ORN),
Time frame: 2 years
Incidence of Tooth Failure
Number or proportion of participants experiencing tooth failure using ClinRad ORN grading system
Time frame: 1, 3, 6, 12, 24, 36 months post RT
Severity of Acute Radiation-Induced Oral Mucositis
Acute oral mucositis severity assessed using the World Health Organization (WHO) Oral Mucositis Grading Scale. Scores range from 0 to 4, where higher scores indicate worse oral mucositis severity (worse outcome).
Time frame: 1 and 3 months post RT
Severity of Acute Radiation-Induced Oral Mucositis
Acute oral mucositis severity assessed using Oral Mucositis Weekly Questionnaire (OMWQ), which evaluates symptoms such as mouth and throat soreness and difficulties with eating, drinking, swallowing, talking, and sleeping. Higher scores indicate more severe oral mucositis symptoms and greater functional impairment (worse outcome).
Time frame: 1 and 3 months post RT
Physician-Assessed Treatment-Related Toxicities
Incidence and severity of treatment-related adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Time frame: 1, 3, 6, 12, 24, 36 months post RT
Patient-Reported Treatment-Related Toxicities
Patient-reported treatment-related adverse events assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Version 1.0.
Time frame: 12, 24 months post RT
Salivary Function
Unstimulated salivary flow rate assessed using the 3-minute Modified Schirmer Test (MST).
Time frame: 1, 3, 6, 12, 24, 36 months post RT
Salivary pH
Salivary pH assessed using pH test strips.
Time frame: 1, 3 and 6, 12, 24 and 36 months post RT
Quality of life (QOL)
Quality of life assessed using the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module (EORTC QLQ-H\&N43).
Time frame: 6, 12 and 24 months post RT
Financial Toxicity
Financial toxicity assessed using the Financial Index of Toxicity (FIT) which evaluates financial strain, psychosocial impacts, and coping behaviors related to treatment-associated costs. Higher scores indicate greater financial toxicity (worse outcome), lower scores indicate less financial burden.
Time frame: 18 months post RT
Health Utility
Health utility assessed using the EuroQol 5-Dimension Questionnaire (EQ-5D) which assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with higher scores indicating better health-related quality of life.
Time frame: 1, 6 and 18 months post RT
Head and Neck Cancer Recurrence Rate
Proportion of participants with recurrent head and neck cancer following treatment, comparing participants receiving Streptococcus salivarius strain SALI-10 plus standard of care with those receiving standard of care alone.
Time frame: 2 years
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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