Improved Oral Health in Head and Neck Cancer Survivors

NCT07173270 | Recruiting

• 2 other identifiers: 2023-05510-012023
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 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

Head and Neck Cancer Squamous Cell Carcinoma; Head and Neck Cancer

Keywords

Head and neck cancer; Nutrition; Oral health; cancer survivors; Quality of Life; healthcare costs

Outcome Measures

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.

  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

  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

  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

  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

  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

  Register data will cover the period from one year prior to diagnosis to five years after the completion of treatment

Study Arms (1)

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.

Other: Oral health support

Interventions

Oral health support 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. 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.

Oral health intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients (≥ 18 years)
• diagnosed with HNC
• scheduled for treatment with curative intent, including RT or CRT with or without surgery

You may not qualify if:

• severe alcoholism
• cognitive impairment
• inability to understand the Swedish language

Sponsors & Collaborators

• Uppsala University: lead
• 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

Study Sites (1)

Uppsala University

Uppsala, 751 85, Sweden

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Ylva Tiblom Ehrsson, Assoc professor, RN

CONTACT

+46707747712; ylva.tiblom.ehrsson@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 15, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): May 31, 2035
• Study Completion (Estimated): September 23, 2045
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)