NCT07883005Not yet recruitingPhase 3
SALI-10 Probiotic to Reduce Osteoradionecrosis and Dental Toxicity Following Radiation Therapy for Head and Neck Cancer
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
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 288 (estimated)
- First submitted
- 6 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 1 Nov 2031
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Head and neck cancer
- NCT number
- NCT07883005
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 288
- From 1 Nov 2026 to the primary completion date, 1 Nov 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are on antibiotics are not eligible except if the last dose of antibiotics was given 2 weeks prior to study registration.
- 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.
Other illness
- 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 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.
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network, Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.