EDMONd - Elemental diet in bowel obstruction

ISRCTN	ISRCTN16862540
DOI	https://doi.org/10.1186/ISRCTN16862540
ClinicalTrials.gov number	NCT03150992
Secondary identifying numbers	32895

Submission date: 06/02/2017
Registration date: 20/02/2017
Last edited: 13/08/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-of-a-new-diet-for-women-with-a-blockage-in-the-bowel-edmond

Contact information

Ms Eleanor Smith
Public

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

ORCID ID	0000-0002-9639-4862
Phone	+44 1483 688547
Email	eleanor.smith@surrey.ac.uk

Dr Agnieszka Michael
Scientific

Department of Clinical and Experimental Medicine
Leggett Building
University of Surrey
Guildford
GU2 7WG
United Kingdom

ORCID ID	0000-0002-7262-6227
Phone	+44 (0)1483 688546
Email	a.michael@surrey.ac.uk

Study information

Study design	Non-randomised; Interventional; Design type: Treatment, Dietary
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	ISRCTN16862540_PIS_04Jan17_V2.pdf
Scientific title	EDMONd – A feasibility study of Elemental Diet as an alternative to parenteral nutrition for patients with inoperable Malignant bowel Obstruction
Study acronym	EDMONd
Study objectives	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(s)	South East Coast – Surrey Research Ethics Committee, 20/12/2016, ref: 16/LO/2079
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/12/2015
Completion date	31/12/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 34; UK Sample Size: 34
Key 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
Key exclusion criteria	1. Bowel obstruction that can be managed with surgical intervention 2. Complete bowel obstruction and inability to tolerate small amount of liquid
Date of first enrolment	01/03/2017
Date of final enrolment	28/02/2019

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Royal Surrey County Hospital

Egerton Road
Guildford
GU2 7XX
United Kingdom

Royal Sussex County Hospital

Eastern Road
Brighton
BN2 5BE
United Kingdom

Guy’s Hospital

Great Maze Pond
London
SE1 9RT
United Kingdom

Sponsor information

Royal Surrey County Hospital NHS Foundation Trust
Hospital/treatment centre

Egerton Road
Guildford
GU2 7XX
England
United Kingdom

Phone	+44 1483 686729
Email	sarah.martin33@nhs.net
"ROR"	https://ror.org/050bd8661

Funders

Funder type

Charity

Target Ovarian Cancer
Private sector organisation / Other non-profit organizations

Location: United Kingdom

Results and Publications

Intention to publish date	28/10/2021
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version V2	04/01/2017	20/02/2017	No	Yes
Poster results	results presented in poster at the European Society for Gynaecological Oncology in (ESGO)	14/12/2020	13/08/2021	No	No
HRA research summary			28/06/2023	No	No

Additional files

ISRCTN16862540_PIS_04Jan17_V2.pdf: Uploaded 20/02/2017

Editorial Notes

13/08/2021: Internal review.
29/04/2021: The scientific contact's details have been updated.
28/04/2021: The following changes have been made:
1. Poster reference added.
2. The intention to publish date has been changed from 31/12/2019 to 28/10/2021.
3. A scientific contact has been added.
26/04/2021: The following changes have been made:
1. The NCT number has been added.
2. Publication reference added.
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.