Title: A cluster randomised trial of clinically-assisted hydration for cancer patients in the last days of life (feasibility study)
Funder: Department of Health (England)

Abstract: Title A cluster randomised trial of clinically-assisted hydration for cancer patients in the last days of life (feasibility study). Background The provision of clinically-assisted hydration (CAH) at the end-of-life is one of the most contentious issues in medicine, and indeed within the general population. The reasons for contention include: a) the lack of evidence for / against CAH; b) the disparate opinions of healthcare professionals about CAH; and c) the generally positive opinions of patients and their carers about CAH. Hypothesis CAH during the last days of life reduces the frequency of delirium / terminal agitation in cancer patients as a result of maintenance of renal perfusion and the prevention of accumulation of toxins and drugs (i.e. prevention of dehydration). Aims/Objectives The aim of the definitive study is to evaluate the utility / role of CAH in cancer patients in the last days of life. The aim of the feasibility study is to answer the question “can this study ( the definitive study ) be done”. The following criteria will be used to determine the success of the feasibility study (and so progression to the definitive study): 1). Recruitment; 2). Retention; 3). Adherence to study procedures; and 4) Safety of study interventions. Methodology The study is a cluster randomised trial, and consent will not be sought from patients / carers (due to the specific nature of the clinical trial). A “cluster representation mechanism” (CRM) will be utilised, including the appointment of site-specific “study guardians” and “study gatekeepers”, who will protect and respect the rights of the cluster and the individual participants within the cluster. Sites will be randomised to either “standard intervention arm A”, or “standard intervention arm B”. Patients in standard intervention arm A will be managed with continuance of oral intake (if appropriate), and regular “mouth care”. Mouth care will be performed at least every four hours, and will correspond to the investigational site’s policy / procedures for oral care in the terminal phase. Patients in standard intervention arm B will be managed with continuance of oral intake (if appropriate), regular “mouth care”, and CAH, i.e. parenteral fluids. Again, mouth care will be performed at least every four hours, and will correspond to the investigational site’s policy / procedures for oral care in the terminal phase. The parenteral fluids may be administered either intravenously or subcutaneously at the discretion of the medical and nursing team. The type of fluid to be administered will be dextrose saline (i.e. 4% dextrose, 0.18% sodium chloride), and the volume to be administered will be 2L/24hr. The primary endpoint of the definitive study is the frequency of delirium / terminal agitation, and this will be assessed using the Modified Richmond Agitation and Sedation Scale (administered every four hours). Other data to be collected include the frequency of pain, respiratory secretions / “death rattle”, dyspnoea, nausea and vomiting, adverse effects from the CAH, and overall survival. In addition, data will be collected on the use of anti-psychotic drugs, sedative drugs, analgesics, anti-secretory drugs, and other end-of-life medication. Sample The sample size is 200, and the number of clusters is eight. Inclusion criteria: Diagnosis of cancer Age ≥ 18 yr Estimated prognosis of ≤ 1 week Patient unable to maintain sufficient oral intake (1L/day) Exclusion criteria: Patient clinically dehydrated Clinical indication for CAH (e.g. hypercalcaemia) Clinical contra-indication to CAH (e.g. cardiac failure) Clinical contra-indication to peripheral cannulation Intravenous fluids / subcutaneous fluids / total parenteral nutrition (TPN) / enteral feeding or fluids already being administered Patient likely to be transferred to another setting for end of life care


Research activity codes: 7.2 END OF LIFE CARE
Health categories: CANCER AND NEOPLASMS