ACTivity as medicine In Oncology for Head and Neck (ACTIOHN): Protocol for a feasibility study investigating a patient-centred approach to exercise for people with head and neck cancer.

BACKGROUND AND AIM: Attempts at personalisation of exercise programmes in head and neck cancer (HaNC) have been limited. The main aim of the present study is to investigate the feasibility and acceptability of introducing a remotely delivered, fully personalised, collaborative, and flexible approach to prescribing and delivering exercise programmes into the HaNC usual care pathway. METHODS: This is a single arm, feasibility study. Seventy patients diagnosed with HaNC will be recruited from two regional HaNC centres in the United Kingdom. Patients will undertake an 8-week exercise programme designed and delivered by cancer exercise specialists. The exercise programme will start any time between the time of diagnosis and up to 8 weeks after completing treatment, depending on patient preference. The content of the exercise programme will be primarily based on patient needs, preferences, and goals, but guided by current physical activity guidelines for people with cancer. The primary outcome measure is retention to the study. Secondary quantitative outcomes are uptake to the exercise programme, different measures of exercise adherence, pre- and post-intervention assessments of fatigue (Multidimensional Fatigue Symptom Inventory-Short Form), quality of life (SF-36), physical activity levels (International Physical Activity Questionnaire-Short Form), and various components of physical fitness. The outcomes of the nested qualitative study are acceptability and feasibility of the intervention evaluated via interviews with patients, health care professionals, and the cancer exercise specialists. Intervention and participant fidelity will be determined using checklists and scrutiny of each patient's logbook and the cancer exercise specialists' meeting notes. Analysis of quantitative data will be via standard summary statistics. Qualitative data will be analysed using thematic analysis. EXPECTED RESULTS: This feasibility study will inform the design and conduct of a future randomised controlled trial. Success will be defined according to a traffic light system for identifying the appropriateness of progression to a randomised controlled trial. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number registry (ISRCTN82505455).

A review of unplanned admissions in head and neck cancer patients undergoing oncological treatment.

AIM: Non-surgical treatment for head and neck cancer (HNC) often results in severe toxicities, which are detrimental to a patient's health and quality of life. There is limited published UK data on unplanned hospital admissions and reasons associated with admission. We aim to identify frequencies and reasons for unplanned hospital admissions, highlighting those patient groups who are most vulnerable. METHODS: A retrospective study of unplanned hospital admissions of HNC patients receiving non-surgical treatment was completed. An inpatient admission was defined as ≥ 1 night spent in the hospital. To test potential demographic and treatment predictors of inpatient admission, a multiple regression model was constructed using the endpoint measure (unplanned admission), as the dependent variable. RESULTS: A cohort of 216 patients was identified over a 7-month period, and 38 of these patients (17%) required an unplanned admission. Treatment type was the only statistically significant predictor of in-patient admission. The majority of admissions were patients receiving chemoradiotherapy (CRT) (58%) with predominant reasons for admission being nausea and vomiting (25.5%) and decreased oral intake/dehydration (30%). Of the patients admitted, 12 had a prophylactic PEG placed pre-treatment, and 18 of 26 admitted without prophylactic PEG required nasogastric tube feeding during their admission. DISCUSSION: Almost one-fifth of HNC patients over this time period required hospital admission; the majority of which can be attributed to treatment toxicities when receiving CRT. This is concurrent with other studies which review the impact of radiotherapy versus CRT. Increased support and monitoring, particularly focused on nutrition, are required for patients with HNC who receive CRT. KEY MESSAGE: This article describes a retrospective review of a patient undergoing non-surgical treatment for head and neck cancer. These patients frequently require unplanned hospital admission. The results indicate that patients undergoing (chemo)radiotherapy are most vulnerable to deterioration and additional support focused on nutrition for these patients is indicated.

Genetic variants associated with mandibular osteoradionecrosis following radiotherapy for head and neck malignancy.

BACKGROUND/AIM: Utilising radiotherapy in the management of head and neck cancer (HNC) often results in long term toxicities. Mandibular osteoradionecrosis (ORN) represents a late toxicity associated with significant morbidity. We aim to identify a panel of common genetic variants which can predict ORN to aid development of personalised radiotherapy protocols. METHOD: Single nucleotide polymorphism (SNP) arrays were applied to DNA samples from patients who had prior HNC radiotherapy and minimum two years follow-up. A case cohort of mandibular ORN was compared to a control group of participants recruited to CRUK HOPON clinical trial. Relevant clinical parameters influencing ORN risk (e.g. smoking/alcohol) were collected. Significant associations from array data were internally validated using polymerase chain reaction (PCR) and pyrosequencing. RESULTS: Following inclusion of 141 patients in the analysis (52 cases, 89 controls), a model predictive for ORN was developed; after controlling for alcohol consumption, smoking, and age, 4053 SNPs were identified as significant. This was reduced to a representative model of 18 SNPs achieving 92% accuracy. Following internal technical validation, a six SNP model (rs34798038, rs6011731, rs2348569, rs530752, rs7477958, rs1415848) was retained within multivariate regression analysis (ROC AUC 0.859). Of these, four SNPs (rs34798038 (A/G) (p 0.006), rs6011731 (C/T) (p 0.018), rs530752 (A/G) (p 0.046) and rs2348569 (G/G) (p 0.005)) were significantly associated with the absence of ORN. CONCLUSION: This is the first genome wide association study in HNC using ORN as the endpoint and offers new insight into ORN pathogenesis. Subject to validation, these variants may guide patient selection for personalised radiotherapy strategies.