Swedish trial to test oral health programme for head and neck cancer survivors

Researchers in Sweden have launched a multicentre randomised controlled trial to evaluate whether a structured oral health care programme can prevent or reduce the late oral complications that follow treatment for head and neck cancer. The study, known as the OHHNC trial, is described in a study protocol published in BMC Cancer and is registered with ClinicalTrials.gov under identifier NCT07173270. It has been ethically approved by the Swedish Ethical Review Authority, and patient inclusion began in September 2025.

Head and neck cancer covers a heterogeneous group of tumours arising in the upper aerodigestive tract, including the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx and salivary glands, as well as cases with an unknown primary site. Treatment typically involves surgery combined with either radiotherapy or chemoradiotherapy. These treatments are associated with substantial morbidity and can have long-lasting adverse effects on oral health. Oral complications in turn can negatively affect health-related quality of life, nutritional status, and social and work-related functioning, which is why the trial team frames oral health as a central concern for survivors rather than a secondary issue.

The trial is designed as a two-armed, superiority randomised controlled trial with an intended sample of 300 participants. Adults aged 18 years or older who are planned for curative-intent treatment for head and neck cancer at the specified tumour sites will be randomised in a one-to-one ratio to either the oral health care programme or standard of care. Patients with severe alcoholism, cognitive impairment, or an inability to understand the Swedish language are excluded from participation. The protocol notes that oral health follow-up for head and neck cancer survivors often lacks consistency and uniformity, and that few oral health care interventions for this group have so far been evaluated within the framework of a randomised controlled trial.

Participants will be assessed before the start of cancer treatment and then at four follow-up points: six months after completion of treatment, and at one, two and three years after that six-month assessment. The primary outcome measure is health-related quality of life. Secondary outcomes include quantitative oral health indicators, return to work, nutritional status, and healthcare-related economic costs. The trial will also collect patient-reported outcome measures covering self-perceived oral health, psychological well-being as assessed through depression, anxiety and stress instruments, and self-efficacy. The listed instruments include the EORTC quality of life questionnaires for cancer and for head and neck cancer, the Depression Anxiety Stress Scale-21, and a General Self-Efficacy scale, with economic evaluation framed around quality-adjusted life years and social insurance data.

Because this is a study protocol, the publication describes planned methods rather than results, and no findings about the effectiveness of the oral health care programme are yet available. The investigators state that the findings have the potential to inform clinical practice and to contribute to the development of more integrated, evidence-based oral healthcare strategies within routine follow-up for head and neck cancer survivors, with the overarching goal of improving their oral health and long-term quality of life. Until the trial completes recruitment and follow-up, questions about whether such a programme improves outcomes remain open, and the trial’s registered design, outcome set and follow-up schedule will determine the strength of the evidence it can eventually provide.

Subject of Research: A Swedish randomised controlled trial protocol evaluating an oral health care programme for head and neck cancer survivors

Article Title: Improved oral health in head and neck cancer survivors (OHHNC study): a study protocol for a multicentre two-armed randomised controlled trial

Article References: Einarsson, S., Almståhl, A., Gyllensten, H., Sjöström, M., Mårell, L., Björ, O., Marklund, L., Farnebo, L., Laurell, G., & Tiblom Ehrsson, Y. (2026). Improved oral health in head and neck cancer survivors (OHHNC study): a study protocol for a multicentre two-armed randomised controlled trial. BMC Cancer, 26(1), Article 1075. https://doi.org/10.1186/s12885-026-16865-8

Image Credits: AI Generated

DOI: 10.1186/s12885-026-16865-8

Keywords: head and neck cancer, oral health, randomised controlled trial, study protocol, health-related quality of life, radiotherapy, survivorship care, patient-reported outcomes, nutritional status, Sweden, Improved, oral