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Improved Oral Health in Head and Neck Cancer Survivors

Study acronym: OHHNC
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints removed 5 → 1 primary endpoints
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Record History

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  1. Notable Primary endpoint(s) modifiedv2 Show 6 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Sep 24, 2025 to Sep 25, 2025
    • Secondary endpoints: 1 to 6
    • Site details revised
    • Collaborators: 7 to 8
    • Study description shortened, about 3 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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?
Trial Details
NCT Number NCT07173270
Lead Sponsor Uppsala University
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
Conditions
(from sponsor)
Head and Neck Cancer Squamous Cell Carcinoma, Head and Neck Cancer
Related terms Head and Neck Neoplasms
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov