Head and Neck Cancer Squamous Cell CarcinomaOHHNCNCT07173270
Improved Oral Health in Head and Neck Cancer Survivors
A study testing Oral health support in people with Head and Neck Cancer Squamous Cell Carcinoma and Head and Neck Cancer, run by Uppsala University at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer Squamous Cell Carcinoma, Head and Neck Cancer
- What is being tested?
- Oral health support
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 25 Sep 2025to 23 Sep 2045
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients (≥ 18 years)
- diagnosed with HNC
- scheduled for treatment with curative intent, including RT or CRT with or without surgery
Who cannot join
- severe alcoholism
- cognitive impairment
- inability to understand the Swedish language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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?
Read the detailed description
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.
- Being tested
- Oral health support
- Keywords
- Head and neck cancer, Nutrition, Oral health, cancer survivors, Quality of Life, healthcare costs
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral health supportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral health intervention | Other | 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. Receives: Other: Oral health support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (6)
Quantitative oral health indicators
Number of remaining teeth, mouth opening ability, presence of caries, periodontitis, salivary composition and osteoradionecrosis
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start25 Sep 2025
- Primary completion31 May 2035 (estimated)
- Study completion23 Sep 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Cancer Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västerbotten, Region Östergötland, The Sjöberg Foundation, The Stig & Ragna Gorthon Foundation, Helsingborg, Swedish Cancer Society, Region Uppsala Public Health and Care, Region Skane, Laryngfonden
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173270
- Sponsor's protocol ID
- 2023-05510-01
- Other IDs
- 2023
- Acronym
- OHHNC
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Einarsson S, Almstahl A, Gyllensten H, Sjostrom M, Marell L, Bjor O, Marklund L, Farnebo L, Laurell G, Tiblom Ehrsson Y. Improved oral health in head and neck cancer survivors (OHHNC study): a study protocol for a multicentre two-armed randomised controlled trial. BMC Cancer. 2026 Sep 7;26(1):1075. doi: 10.1186/s12885-026-16865-8.
PubMed 42717322
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Oral Health in Head and Neck Cancer Survivors
- ClinicalTrials.gov ID
- NCT07173270
- Acronym / sponsor ID
- OHHNC / 2023-05510-01
- Keywords
- Head and neck cancer, Nutrition, Oral health, cancer survivors, Quality of Life, healthcare costs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Region Västerbotten, Region Östergötland, The Sjöberg Foundation, The Stig & Ragna Gorthon Foundation, Helsingborg, Swedish Cancer Society, Region Uppsala Public Health and Care, Region Skane, Laryngfonden
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 31 May 2035 (estimated)
- Study completion
- 23 Sep 2045 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral health intervention | Other | Other: Oral health supportThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients (≥ 18 years)
- diagnosed with HNC
- scheduled for treatment with curative intent, including RT or CRT with or without surgery
Key exclusion criteria (3 listed)
- severe alcoholism
- cognitive impairment
- inability to understand the Swedish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral health supportThe 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. | Other | Oral health intervention |
Primary outcome
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.
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.
6 secondary outcomes
Quantitative oral health indicators
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
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
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
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Derived from this study: PubMed 42717322Einarsson S, Almstahl A, Gyllensten H, Sjostrom M, Marell L, Bjor O, Marklund L, Farnebo L, Laurell G, Tiblom Ehrsson Y. Improved oral health in head and neck cancer survivors (OHHNC study): a study protocol for a multicentre two-armed randomised controlled trial. BMC Cancer. 2026 Sep 7;26(1):1075. doi: 10.1186/s12885-026-16865-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral health support in people with Head and Neck Cancer Squamous Cell Carcinoma and Head and Neck Cancer, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ylva Tiblom Ehrsson, Assoc professor, RN (+46707747712, ylva.tiblom.ehrsson@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07173270, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.