Trial · NCT07883005
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Secondary | Health Utility | 1, 6 and 18 months post RT | 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. |
| Secondary | Head and Neck Cancer Recurrence Rate | 2 years | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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