Clinical trial · Interventional
CRT Hydration in the Last Days of Life (Feasibility Study)
A Cluster Randomised Trial of Alternative Forms of Hydration in Cancer Patients in the Last Days of Life (Feasibility Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 a result many individuals do not receive such treatment (although they do receive fluids by mouth, and regular mouth care). The researchers want to undertake a large study ("main 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 England \& Wales; 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 a drip, and treatment of any symptoms. Patients will be assessed on a four hourly basis, and any uncontrolled symptoms 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 given by a drip will also be recorded. Involvement in the study will not interfere with the patient's general care, and there will be no additional blood or other tests.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinically Assisted Hydration arm | Other | — | UNRESOLVED |
| Non-Clinically Assisted Hydration arm | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Non-Clinically Assisted Hydration arm
- description
- The interventions utilised within this trial are representative of standard clinical practice * Continuance of oral intake (if appropriate) * Regular (4 hourly) mouth care * Standard management of pain and other symptoms in the terminal phase.
- interventionNames
- Other: Non-Clinically Assisted Hydration arm
- type
- ACTIVE_COMPARATOR
- label
- Clinically Assisted Hydration arm
- description
- The interventions utilised within this trial are representative of standard clinical practice * Continuance of oral intake (if appropriate) * Regular (4 hourly) mouth care * Clinically-assisted hydration * Standard management of pain and other symptoms in the terminal phase
- interventionNames
- Other: Clinically Assisted Hydration arm
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
* Patient has hyperactive delirium ("terminal agitation") at present
* Patient has had hyperactive delirium ("terminal agitation") in the last 24hr
* Clinical indication for clinically-assisted hydration (e.g. hypercalcaemia)
* Clinical contra-indication to clinically-assisted hydration (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 (e.g. home, hospice)References
Publications (2)
- DERIVEDDavies AN, Waghorn M, Webber K, Johnsen S, Mendis J, Boyle J. A cluster randomised feasibility trial of clinically assisted hydration in cancer patients in the last days of life. Palliat Med. 2018 Apr;32(4):733-743. doi: 10.1177/0269216317741572. Epub 2018 Jan 18. PMID 29343167
- DERIVEDDavies A, Waghorn M, Boyle J, Gallagher A, Johnsen S. Alternative forms of hydration in patients with cancer in the last days of life: study protocol for a randomised controlled trial. Trials. 2015 Oct 14;16:464. doi: 10.1186/s13063-015-0988-3. PMID 26466809