Improved Oral Health in Head and Neck Cancer Survivors

NCT07173270 | Not Yet Recruiting

• 1 other identifier: 2023-05510-01
• 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 can prevent or reduce late oral side effects in patients with head and neck cancer following treatment. The main questions it aims to answer are:

• Can additional support from hospital dental care for cancer survivors, up to three years after completion of treatment, improve patients' oral health, nutritional status, quality of life, and reduce stress and anxiety compared to standard care?
• Are there differences in oral health outcomes between younger and older individuals receiving additional support from hospital dental care?
• Can additional support from hospital dental care for cancer survivors, up to three years after completion of treatment, reduce the duration of sick leave and enhance patients' ability to return to work compared to standard care?
• Can additional support from hospital dental care for cancer survivors, up to five years after completion of treatment, be cost-effective from a health economic perspective? Researchers will compare oral care programme to standard care to see if the programme works to improve oral health, reduce oral symptoms and problems, enhance quality of life and lower the economic costs of healthcare Participants will: Participate in an oral care programme, every three months for three years.

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 (5)

• Number of remaining teeth

  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

• Maximum interincisal opening (MIO)

  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

• Presence of caries

  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

• Loss of supporting tissue (periodontitis)

  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

• Osteoradionecrosis.

  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)

• 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.

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
• Sjöbergstiftelsen: collaborator
• The Stig & Ragna Gorthon Foundation, Helsingborg: collaborator
• Swedish Cancer Society: collaborator
• Region of Uppsala: collaborator
• Region Skane: collaborator

Study Sites (1)

Uppsala University

Uppsala, 751 85, Sweden

Location

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 24, 2025
• Primary Completion (Estimated): May 31, 2035
• Study Completion (Estimated): September 23, 2045
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)