Condition category
Cancer
Date applied
06/02/2017
Date assigned
20/02/2017
Last edited
16/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Ms Eleanor Smith

ORCID ID

http://orcid.org/0000-0002-9639-4862

Contact details

Clinical Trials Office Room 07PGMO2
Department of Microbial & Cellular Sciences
Institute of Biosciences and Medicine
Leggett Building
Faculty of Health and Medical Sciences
Daphne Jackson Road
Guildford
GU2 7WG
United Kingdom
+44 1483 688547
eleanor.smith@surrey.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32895

Study information

Scientific title

EDMONd – A feasibility study of Elemental Diet as an alternative to parenteral nutrition for patients with inoperable Malignant bowel Obstruction

Acronym

EDMONd

Study hypothesis

The aim of the study is to provide ‘proof of concept’ of Elemental Diet (ED) as an acceptable/useful feeding option for patients with inoperable bowel obstruction (IBO) and to examine the impact of ED on quality of life.

Ethics approval

South East Coast – Surrey Research Ethics Committee, 20/12/2016, ref: 16/LO/2079

Study design

Non-randomised; Interventional; Design type: Treatment, Dietary

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Cancer, Primary sub-specialty: Gynaecological Cancers; UKCRC code/ Disease: Cancer/ Malignant neoplasms of female genital organs

Intervention

All participants receive the Elemental Diet (ED). The ED will be provided in the form of Elemental 028 Extra Liquid. Patients will be assessed by a clinician and specialist oncology dietician and given an individual plan of ED introduction. ED requires phased introduction to achieve tolerance of the course of 3-5 days, under the supervision of the study dietician. Following introduction of ED, patients will be discharged from the hospital (as per normal clinic practise) and followed up for 2 weeks. They will have a telephone follow up assessment once a week for two weeks. All other assessments will follow the standard of care. During the follow up assessment, patients will be assessed using the Memorial Symptom Assessment Scale and asked to complete a nutritional diary and Quality of Life questionnaires.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Taste acceptability of ED is measured on 1-5 grading in nutritional diary once per week for two weeks
2. Incidence of vomiting is measured on MSAS scale at day 1 of ED induction, discharge and once per week for two weeks
3. Incidence of pain is measured on MSAS scale at day 1 of ED induction, discharge and once per week for two weeks

Secondary outcome measures

1. The number (proportion) of patient who can tolerate ED following presentation with IBO and can subsequently be treated with palliative chemotherapy is measured by reviewing hospital case notes at patient completion of study
2. The number of patients alive at the end of the study is measured by reviewing hospital case notes at patient completion of study
3. Health Related Quality of Life is measured on EORTC-QLQ-C30 at day 1 of ED induction, discharge and once per week for two weeks
4. Nutritional Intake is measured by the number of ED cartons taken in 24 hours
5. Incidence of vomiting is measured on MSAS scale at day 1 of ED induction, discharge and once per week for two weeks

Overall trial start date

01/12/2015

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years and over
2. Confirmed inoperable bowel obstruction due to disseminated malignancy
3. Ability to tolerate 500 ml of liquid
4. Capacity to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 34; UK Sample Size: 34

Participant exclusion criteria

1. Bowel obstruction that can be managed with surgical intervention
2. Complete bowel obstruction and inability to tolerate small amount of liquid

Recruitment start date

01/03/2017

Recruitment end date

28/02/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom

Trial participating centre

Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Trial participating centre

Guy’s Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Royal Surrey County Hospital NHS Foundation Trust

Sponsor details

Egerton Road
Guildford
GU2 7XX
United Kingdom
+44 1483 686729
sarah.martin33@nhs.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Target Ovarian Cancer

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed scientific journal, conference presentation and publication online.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/10/2017: Cancer Help UK lay summary link added to plain English summary field 15/09/2017: Internal review. 06/06/2017: Internal review. 27/02/2017: Verified study information with principal investigator.