Improved Oral Health in Head and Neck Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUppsala University
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients (≥ 18 years)
diagnosed with HNC
scheduled for treatment with curative intent, including RT or CRT with or without surgery
Disqualifiers
severe alcoholism
cognitive impairment
inability to understand the Swedish language
Trial design
Design model
Single group
Treatments tested in this trial
Oral health support
Other interventionThe 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. During visits to the dental hygienist, they will be asked about oral hygiene habits, fluoride use, dry mouth problems, and dietary habits (including intake of easily degradable carbohydrates). Oral dryness will be assessed using the Clinical Oral Dryness Scale. The stimulated salivary secretion and buffering capacity will be assessed, and the ability to open the mouth, cariological and periodontal status and registered plaque. Based on the results of the clinical examination, the patient will get individually tailored advice and recommendations on oral hygiene, fluoride use, dry mouth relief, and support in reducing the intake of food items and drinks with high sugar content. Professional oral care will be given, and fluoride applications when indicated.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Oral health interventionOther 1 intervention
Trial outcomes
Primary outcomes
1
Health-related quality of life
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.
Time frame
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.Secondary outcomes
1
Quantitative oral health indicators
Number of remaining teeth, mouth opening ability, presence of caries, periodontitis, salivary composition and osteoradionecrosis
Time frame
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 years2
Generic cancer-related HRQoL
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores are linearly transformed to a 0-100 scale. Higher scores indicate better functioning and quality of life for the functional and global health status scales, whereas higher scores indicate more severe symptoms for the symptom scales and single-item measures.
Time frame
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.3
Return to work
Return to work and sick leave patterns.
Time frame
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 History taking from research and clinical nurses.4
Nutritional status
Malnutrition according to the Global Leadership Initiative on Malnutrition (GLIM) criteria
Time frame
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Uppsala University
Lead sponsor
Region Västerbotten
Collaborator
Region Östergötland
Collaborator
The Sjöberg Foundation
Collaborator
The Stig & Ragna Gorthon Foundation, Helsingborg
Collaborator
Swedish Cancer Society
Collaborator
Region Uppsala Public Health and Care
Collaborator
Region Skane
Collaborator
Laryngfonden
Collaborator
Source ClinicalTrials.gov