Improved Oral Health in Head and Neck Cancer Survivors

Not Applicable

Not yet recruiting

• Conditions: Head and Neck Cancer Squamous Cell Carcinoma; Head and Neck Cancer

• Registration Number: NCT07173270
• Lead Sponsor: Uppsala University

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.

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 chemotherapy. 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 head and neck cancer. 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 head and neck cancer 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 Timeline

• Study First Submitted: 2025-08-26
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-15
• Study Start: 2025-09-24
• Primary Completion: 2035-05-31
• Study Completion: 2045-09-23

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. Developed by the European Organization for Research and Treatment of Cancer. General questionnaire for patients with cancer, 30 questions. Measures physical, role, emotional, cognitive and social functioning. One question about overall quality of life and nine questions about various symptoms, such as fatigue, pain and sleep difficulties. Likert scale with four response options. A higher score suggests a better level of functioning, while a higher score suggests more severe problems regarding symptoms.

Trial Locations

Locations (1)

Uppsala University; 🇸🇪 Uppsala, Sweden