Head and Neck CancerPhase 3DIAMONDNCT07883005
SALI-10 Probiotic to Reduce Osteoradionecrosis and Dental Toxicity Following Radiation Therapy for Head and Neck Cancer
A Phase 3 study testing Experimental drug in people with Head and Neck Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Experimental drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2026to 1 Nov 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Ali Hosni Abdalaty, 416-946-2124, ali.hosni@uhn.ca
About this study
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
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Standard of Care (SOC), Experimental drug
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SOC)Other
Participants will receive standard of care.
Experimental drugDrug
- salivarius SALI10 probiotic lozenge
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy | Other | Standard Of Care Receives: Other: Standard of Care (SOC) |
| SALI-10 | Experimental | Not described Receives: Other: Standard of Care (SOC); Drug: Experimental drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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),
Measured: 2 years
Secondary outcomes (11)
Incidence of Tooth Failure
Number or proportion of participants experiencing tooth failure using ClinRad ORN grading system
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 12, 24 months post RT
Salivary Function
Unstimulated salivary flow rate assessed using the 3-minute Modified Schirmer Test (MST).
Measured: 1, 3, 6, 12, 24, 36 months post RT
Salivary pH
Salivary pH assessed using pH test strips.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2031 (estimated)
- Study completion1 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883005
- Sponsor's protocol ID
- OCREB 5474
- Acronym
- DIAMOND
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07883005
- Acronym / sponsor ID
- DIAMOND / OCREB 5474
- Conditions
- Head and Neck Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2031 (estimated)
- Study completion
- 1 Nov 2031 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy | Other | Other: Standard of Care (SOC)Standard Of Care |
| SALI-10 | Experimental | Other: Standard of Care (SOC), Drug: Experimental drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care (SOC)Participants will receive standard of care. | Other | Radiation Therapy, SALI-10 |
| Experimental drugS. salivarius SALI10 probiotic lozenge | Drug | SALI-10 |
Primary outcome
Incidence of Major Adverse Dental Events (MADE)
Time frame: 2 years
Major adverse dental events (MADE), defined as tooth failure and/or grade 2 or higher jaw osteoradionecrosis (ORN),
11 secondary outcomes
Incidence of Tooth Failure
Time frame: 1, 3, 6, 12, 24, 36 months post RT
Severity of Acute Radiation-Induced Oral Mucositis
Time frame: 1 and 3 months post RT
Severity of Acute Radiation-Induced Oral Mucositis
Time frame: 1 and 3 months post RT
Physician-Assessed Treatment-Related Toxicities
Time frame: 1, 3, 6, 12, 24, 36 months post RT
Patient-Reported Treatment-Related Toxicities
Time frame: 12, 24 months post RT
Salivary Function
Time frame: 1, 3, 6, 12, 24, 36 months post RT
Salivary pH
Time frame: 1, 3 and 6, 12, 24 and 36 months post RT
Quality of life (QOL)
Time frame: 6, 12 and 24 months post RT
Financial Toxicity
Time frame: 18 months post RT
Health Utility
Time frame: 1, 6 and 18 months post RT
Head and Neck Cancer Recurrence Rate
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental drug in people with Head and Neck Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Hosni Abdalaty (416-946-2124, ali.hosni@.uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Adverse Dental Events (MADE) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.