An interventional study of Oral health support in Head and Neck Cancer Squamous Cell Carcinoma and Head and Neck Cancer, sponsored by Uppsala University. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Uppsala University · Not applicable, Interventional, and Prevention
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Among 34 studies in Head and Neck Neoplasms with a site in Sweden — 10 open to participants now, 13 under way, 2 of them phase 3. Head and Neck Neoplasms · Sweden.
Among the 34 studies in Head and Neck Neoplasms with a site in Sweden, this one is the 7th largest by planned enrollment of the 26 interventional ones that give a count, is one of 2 that started in 2025, is one of 9 with no phase, reaches primary completion later than 12 of the 12 other live ones, and was the 31st registered.
2,713 studies on the registry are indexed under Head and Neck Neoplasms; 596 are open to participants now.
Browse Head and Neck Neoplasms studies →10 of the 34 studies in Head and Neck Neoplasms with a site in Sweden are open now. Recruiting first, the newest first:
Region Skane · Sites in Sweden
Ages 18+
OncoZenge AB · Sites in Sweden, Denmark, Germany and 1 more country
Ages 18–80
Karolinska University Hospital · Sites in Sweden
Ages 18+
Lars Olaf Cardell · Sites in Sweden
Ages 18+
GlaxoSmithKline · Sites in Sweden, United States, Argentina and 28 more countries
Ages 18+
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 453 Head and Neck Neoplasms studies recruiting now, 345 (76%) set no upper age limit and 51 (11%) stop at 75 or younger; 21 take children under 18; 27 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 3 · Phase 3 10 · Phase 4 2
First in 2003; this study’s year is marked. 2 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 300 is above the median of 46 across 2,033 interventional studies indexed under Head and Neck Neoplasms.
Median enrollment 187 across the 26 interventional studies, 119 across the 8 observational. Of the 20 that completed or were terminated, 9 (45%) have results posted.
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12 of 34 have an industry lead sponsor. The 10 most frequent:
Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.
Uppsala University has 4 studies filed under Head and Neck Neoplasms — fewer than ten, so there is no comparison to draw.
3 of the studies in Head and Neck Neoplasms with a site in Sweden that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07672236Phase 3OncoZenge ABA Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer. | 2026-12-23 |
| NCT03481647Göteborg UniversityEvaluation of an Oral Care Programme for Head and Neck Cancer Patients | 2026-12-31 |
| NCT06639191Karolinska University Hospital[177Lu]Lu-AKIR001 First-in-human Study | 2027-11-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 34 studies in Head and Neck Neoplasms with a site in Sweden, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
In Sweden, approximately 1,800 individuals are diagnosed with head and neck cancer (HNC) each year. Treatment includes radiotherapy or surgery, sometimes combined with systemic anti-cancer therapy (SACT). The five-year survival rate for the entire group is now approximately 70%. Despite improved five-year survival during the last two decades, side effects such as decreased salivation, difficulty swallowing, pain and radiation-induced caries are common, which negatively affect quality of life. Thus, therapeutic improvements that support oral health are highly demanded among the large group surviving HNC. The research project is a multicentre randomised controlled trial evaluating the effectiveness of an oral care programme in preventing or reducing late oral side effects in patients with HNC following treatment. Through a collaborative effort across five healthcare regions, this study aims to provide robust evidence of the efficacy of interventions designed to improve oral health outcomes and enhance the overall quality of life among HNC survivors. The intervention group will visit a dental hygienist every 3 months for oral health examination and treatment, whereas the control group will receive standard care (i.e., they will contact dental care on their own, if needed). Data collection will include patient-reported outcome measures, nutritional status, oral and dental assessments, as well as saliva and blood samples. The goal is to enhance the understanding of how oral health and quality of life can be improved in this vulnerable group, as well as how health economic costs can be reduced.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Oral health support
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. 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.
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.
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 years
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.
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.
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 years
Healthcare-related economic costs
Time frame: Register data will cover the period from one year prior to diagnosis to five years after the completion of treatment
Patient-reported outcome measures (PROMs)
Self-reported oral health, psychological well-being (depression, anxiety and stress), and self-efficacy
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
Plan to share: No
Started Sep 2025 (actual). Primary completion is estimated for May 2035, 116 months after the start.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 116 months is above that.
Counting every sponsor, half of 455 studies reached it within 33 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
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