Title: A Randomised Pilot Study of Therabite use versus Wooden Spatula in the amelioration of Trismus in Head and Neck Cancer Patients
Funder: Department of Health (England)

Abstract: Background Annually~5500 cases of mouth cancer are diagnosed in the UK. Treatments may affect patients’ appearance or cause loss of essential functions. Patients attending a focus group in our hospital concurred that restricted mouth opening had a significant impact on reducing their quality of life (QOL). With up to 86% of patients receiving radiation for mouth cancer developing some degree of limitation in jaw opening (trismus), impacting on nutritional intake, dental hygiene and all aspects of QOL. Initial evidence from a handful of small-scale and often uncontrolled studies have provided indications that passive mouth exercises using a device called Therabite may significantly improve trismus. Hence, there is a need for a study to provide concrete evidence as to whether such devices are helpful. Aims This is a feasibility study as there are uncertainties around compliance with exercise programmes, tolerability of intervention during radiotherapy and its associated mucositis and lack of clarity on which levels of mouth opening improvement impact on quality of life. The primary aim is to evaluate the feasibility of conducting a randomised controlled trial comparing Therabite® 1 versus wooden spatulas (standard care) in patients with stage 3 and 4 oral/oropharyngeal cancer. Secondary aims are (i) to assess whether a Therabite or wooden Spatula intervention improves patients’ quality of life using validated QoL questionnaires; and (ii) whether the intervention can reduce the level and cost of post-treatment clinical management/health care utilisation required by mouth cancer patients. Plan of Investigation Design: This is a feasibility trial of a trismus intervention. Patients & Settings: Patients with stage 3 and 4 oral/oropharyngeal cancer managed either by primary (chemo)radiotherapy or surgery involving free tissue transfer followed by (chemo)radiotherapy will be recruited from two leading Head & Neck cancer centres in the North West (Manchester and Liverpool). Procedures: Patients will be randomly assigned to receive wooden spatulas or Therabites and instructed to perform their mouth exercises according to a set protocol. Patients will be asked to complete the EORTC-QOL 30&H&N35 scale prior to (chemo)radiotherapy, 3 months and 6 months following interventions, along with maximum mouth opening measurements. Health Economic Evaluations: EQ-5D and ICECAP will be completed 3 and 6 months Potential Impact This intervention should potentially see a substantially improved QOL of these patients. These patients have among the lowest QoL levels and highest suicide rates of all cancer patients2. This study was initiated at the request of the Manchester Oral & Maxillo-Facial patient group and supported by the Merseyside Patient and Carer Research Group. We anticipate this research will lead to alleviation of restriction/pain with mouth opening, inability to eat in front of friends/family or in public, poor oral hygiene or inability to have dentures fitted as well as hamper access for clinical assessment of local recurrence. This evidence-base will immediately benefit the wider NHS by potentially reducing the level of post-treatment clinical,dental and psychological management of these patients.


Research activity codes: 6.7 PHYSICAL
Health categories: CANCER AND NEOPLASMS