Trial · NCT07883005
SALI-10 Probiotic to Reduce Osteoradionecrosis and Dental Toxicity Following Radiation Therapy for Head and Neck Cancer
NCT07883005, Phase 3, Not yet recruiting, University Health Network, Toronto
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SALI-10 Probiotic to Reduce Osteoradionecrosis and Dental Toxicity Following Radiation Therapy for Head and Neck Cancer. Trials, record NCT07883005. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07883005
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SALI-10 Probiotic to Reduce Osteoradionecrosis and Dental Toxicity Following Radiation Therapy for Head and Neck Cancer
- NCT number
- NCT07883005
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 288 participants, estimated
- Lead sponsor
- University Health Network, Toronto
- Conditions
- Head and Neck Cancer
- Interventions
- Standard of Care (SOC), Experimental drug
- First posted
- 2026-10-20
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Major Adverse Dental Events (MADE) | 2 years | Major adverse dental events (MADE), defined as tooth failure and/or grade 2 or higher jaw osteoradionecrosis (ORN), |
| Secondary | Incidence of Tooth Failure | 1, 3, 6, 12, 24, 36 months post RT | Number or proportion of participants experiencing tooth failure using ClinRad ORN grading system |
| Secondary | Severity of Acute Radiation-Induced Oral Mucositis | 1 and 3 months post RT | 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). |
| Secondary | Severity of Acute Radiation-Induced Oral Mucositis | 1 and 3 months post RT | 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). |
| Secondary | Physician-Assessed Treatment-Related Toxicities | 1, 3, 6, 12, 24, 36 months post RT | 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. |
| Secondary | Patient-Reported Treatment-Related Toxicities | 12, 24 months post RT | 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. |
| Secondary | Salivary Function | 1, 3, 6, 12, 24, 36 months post RT | Unstimulated salivary flow rate assessed using the 3-minute Modified Schirmer Test (MST). |
| Secondary | Salivary pH | 1, 3 and 6, 12, 24 and 36 months post RT | Salivary pH assessed using pH test strips. |
| Secondary | Quality of life (QOL) | 6, 12 and 24 months post RT | Quality of life assessed using the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module (EORTC QLQ-H\&N43). |
| Secondary | Financial Toxicity | 18 months post RT | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07883005
GET https://conductscience.org/api/trials/v1/NCT07883005/registered