NCT02344927

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2014

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

June 4, 2014

Last Update Submit

March 14, 2016

Conditions

Cancer

Keywords

CancerEnd-of-life careClinically-assisted hydration

Outcome Measures

Primary Outcomes (1)

  • Recruitment rate

    Sample size is 200

    Up to 12 months

Secondary Outcomes (3)

  • Retention (% participants complete the study in a one year period)

    Up to 12 months

  • Adherence (% nursing observation completed in a one year period)

    Up to 12 months

  • Treatment related adverse events

    Up to 12 months

Study Arms (2)

Non-Clinically Assisted Hydration arm

ACTIVE COMPARATOR

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.

Other: Non-Clinically Assisted Hydration arm

Clinically Assisted Hydration arm

ACTIVE COMPARATOR

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

Other: Clinically Assisted Hydration arm

Interventions

Non-Clinically Assisted Hydration armOTHER

Best supportive care. Continuance of oral intake (if appropriate) and regular mouth care

Non-Clinically Assisted Hydration arm
Clinically Assisted Hydration armOTHER

Best supportive care. Continuance of oral intake (if appropriate) and regular mouth care, and clinically assisted hydration.

Clinically Assisted Hydration arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of cancer
  • Age ≥ 18 yr
  • Estimated prognosis of ≤ 1 week
  • Patient unable to maintain sufficient oral intake (1L / day)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

St Clare Hospice

Harlow, Essex, CM179JX, United Kingdom

Location

Leckampton Hall Hospice

Cheltenham, Gloucestershire, GL53 0QJ, United Kingdom

Location

Pilgrims Hospice

Canterbury, Kent, CT2 8JA, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, Lancashire, M20 4BX, United Kingdom

Location

New Cross Hospital

Wolverhampton, Midlands, WV10 0QP, United Kingdom

Location

St Margaret's Hospice

Taunton, Somerset, TA1 5HA, United Kingdom

Location

St Giles Hospice

Lichfield, Staffordshire, WS14 9LH, United Kingdom

Location

The Royal Surrey County Hospital NHS Foundation Trust

Guildford, Surrey, GU2 7XX, United Kingdom

Location

St Catherine's Hospice

Crawley, Sussex, RH10 6BH, United Kingdom

Location

St Mary Hospice

Birmingham, West Midlands, B29 7DA, United Kingdom

Location

St Richards Hospice

Worcester, Worcestershire, WR5 2QT, United Kingdom

Location

Velindre Cancer centre

Cardiff, CF14 2TL, United Kingdom

Location

Related Publications (2)

  • Davies 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: 29343167DERIVED

  • Davies 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: 26466809DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Andrew Davies

    Royal Surrey County Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2014

First Posted

January 26, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 15, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(12)