Clinical trial · Interventional
Improved Oral Health in Head and Neck Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn if an oral care programme, designed as a multicentre two-armed randomised controlled trial (RCT), can prevent or mitigate late oral sequalae following completion of head and neck cancer (HNC) treatment, and assessing its impact on health-related quality of life (HRQoL), oral health, work ability, nutritional status, psychological well-being, and healthcare-related economic costs. The intervention consists of an oral care programme given to the intervention group (HNC survivors) from six months after the end of treatment and every three months for three years. The main questions it aims to answer are: * Does the intervention improve oral health, nutritional status, HRQoL, and reduce stress and anxiety compared with standard care? * Does the intervention reduce the duration of sick leave and improve return-to-work outcomes compared with standard care? * Is the intervention cost-effective from a health economic perspective? * Does the intervention improve patients' self-efficacy in managing their oral health and related challenges compared with standard care? * Does the intervention influence self-reported oral health, oral health-related behaviours, and oral health knowledge over time compared with standard care? * Do the effects of the intervention differ according to age, sex and sociodemographic factors? * Does the intervention affect salivary composition and salivary biomarkers over time compared with standard care?
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Head and Neck Cancer Squamous Cell Carcinoma | Head and Neck Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral health support | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Oral health intervention
- description
- The intervention group will receive examination and treatment by a dental hygienist every 3 months starting 6 months after completion of RT/CRT up to 3 years.
- interventionNames
- Other: Oral health support
Primary outcomes (1)
- measure
- Health-related quality of life
- timeFrame
- Data will be collected before RT/CRT begins (baseline), at 6 months after the completion of RT/CRT (randomisation, start of intervention), and at one, two and three years.
- description
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Cancer Module (EORTC QLQ-HN43) EORTC QLQ-HN43 scores are linearly transformed to a 0-100 scale. Higher scores indicate greater symptom burden and more severe disease- or treatment-related problems, corresponding to poorer health-related quality of life.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients (≥ 18 years) * diagnosed with HNC * scheduled for treatment with curative intent, including RT or CRT with or without surgery Exclusion Criteria: * severe alcoholism * cognitive impairment * inability to understand the Swedish language
References
Publications (0)
Data not yet available