CAH (feasibility study)
Research type
Research Study
Full title
A cluster randomised trial of clinically-assisted hydration for cancer patients in the last days of life (feasibility study)
IRAS ID
154323
Contact name
Andrew Davies
Contact email
Sponsor organisation
Research and Enterprise Support,University of Surrey
Research summary
It is unclear whether the use of fluids given by a "drip" is beneficial to cancer patients in the last days of life, and as result many individuals do not receive such treatment (although they do receive fluids by mouth, and regular mouth care). The researchers wants to undertake a large study ("definitive study") to determine the benefits of fluids given by a drip, but first need to undertake a small study ("feasibility study") to ensure that the main study can be done.
The feasibility study will be done in twelve units (hospitals, hospices) in the UK; each unit will be allocated a treatment at random, and all patients in the unit will receive that treatment (if appropriate). Standard treatment A consists of drinking fluids (if possible), regular mouth care, and treatment of any symptoms; standard treatment B consists of drinking fluids (if possible), regular mouth care, fluids by drip, and treatment of any symptoms.
Patient will be assessed on a four hourly basis, and any uncontrolled symptom will be recorded. The main symptom of interest is agitation ("delirium"), which has multiple causes, including dehydration and kidney failure. Uncontrolled symptoms will be appropriately treated, e.g. patients with pain will be given painkillers. Equally problems relating to the fluids will also be recorded.
A study guardian (i.e. independent healthcare professional) will ensure that only appropriate patients are entered into the study and in the event of any problem, will ensure that relevant patient is removed from the study (and that the problems appropriately treated). Involvement in the study will not interfere with the patient's general care and there will be no additional blood or other tests.
REC name
London - South East Research Ethics Committee
REC reference
14/LO/1218
Date of REC Opinion
24 Jul 2014
REC opinion
Unfavourable Opinion