EDMONd - Elemental Diet in Bowel Obstruction

Ovarian Cancer Clinical Trial

— EDMONd  

Official title:

A Feasibility Study of Elemental Diet as an Alternative to Parenteral Nutrition for Patients With Inoperable Malignant Bowel Obstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03150992
• Other study ID #: 16/LO/2079
• Secondary ID: 32895
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2017
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: Royal Surrey County Hospital NHS Foundation Trust
• Contact: Eleanor Smith
• Phone: 01483 688547
• Email: eleanor.smith[@]surrey.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A feasibility study to provide 'proof of concept' of Elemental Diet (ED) as an acceptable/ useful feeding option for patient with inoperable malignant bowel obstruction and to examine the impact of ED on quality of life

Description:

The aim of this study is to determine whether Elemental Diet (a type of drink that contains an elemental protein source known as amino acids) can be tolerated by patients with inoperable bowel blockage who can no longer eat and are only able to swallow small amount of fluid. The objective is to find out whether elemental diet (ED) can be used as an acceptable nutrition and whether it improves the quality of life. Bowel blockage is a common complication in patients with ovarian cancer. Unfortunately when the cancer is advanced, this blockage can occur in many parts of the bowel therefore surgery is not possible. Every year in the UK some publications report the rate as high as 50% . One way to feed patients with bowel blockage is through the veins; this is known as parenteral nutrition (PN) however PN is rarely used in United Kingdom. Patients with malignant bowel blockage are often able to swallow small amounts of liquid but if they have no PN they are only able to survive for 2-3 weeks and the psychological as well as physical impact on patients and the family are very distressing. ED is a type of a drink which contains an elemental protein source known as amino acids. ED drinks are almost totally absorbed in the upper part of the bowel and therefore could be absorbed even in patients who have bowel blockage which usually develops lower down in the gut. If this study is successful and proves that ED can be tolerated and provide nutrition to patients with inoperable bowel blockage it will be a big step towards improving the quality of life at the final stage of cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age > 18 years

• Confirmed inoperable bowel obstruction due to disseminated malignancy

• Ability to tolerate 500ml of liquid

• Capacity to give informed consent

Exclusion Criteria:

• Bowel obstruction that can be managed with surgical intervention

• Complete bowel obstruction and inability to tolerate small amount of liquid

Related Conditions & MeSH terms

• Abdominal Neoplasm
• Abdominal Neoplasms
• Bowel Obstruction
• Carcinoma, Ovarian Epithelial
• Intestinal Obstruction
• Metastatic Ovarian Cancer
• Neoplasms
• Ovarian Cancer
• Ovarian Disease
• Ovarian Diseases
• Ovarian Neoplasms
• Peritoneal Diseases
• Peritoneal Neoplasms
• Primary Peritoneal Carcinoma

Intervention

Dietary Supplement:
• Elemental 028 Extra Liquid
A nutritionally complete, liquid elemental diet consisting of a mixture of essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals, trace elements and flavourings with sugars & sweeteners.

Locations

Country	Name	City	State
United Kingdom	Royal Surrey County Hospital NHS Foundation Trust	Guildford	Surrey

Sponsors (3)

Lead Sponsor	Collaborator
Royal Surrey County Hospital NHS Foundation Trust	Target Ovarian Cancer, University of Surrey

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Taste acceptability of ED	Taste of at least one flavor of ED graded as 2 out of 5 by patient on nutritional diary taste acceptability scale (1=I really like the taste, 2=I like the taste, 3=The taste is acceptable, 4=I do not like the taste but can drink it, 5=I do not like the taste and cannot drink it).	Two weeks
Primary	Change in incidence of vomiting	No deterioration in incidence of vomiting as measured on MSAS scale. Grading 1 (occurring rarely) or 2 (occurring occasionally) is acceptable. Deterioration considered as change to 3 (occurring frequently) or 4 (occurring almost constantly).	Two weeks
Primary	Change in incidence of pain	No deterioration in incidence of abdominal pain as measured on MSAS scale. Grading 1 (occurring rarely) or 2 (occurring occasionally) is acceptable. Deterioration considered as change to 3 (occurring frequently) or 4 (occurring almost constantly).	Two weeks
Secondary	The number of patients who can tolerate ED following presentation with IBO and can subsequently be treated with palliative chemotherapy	Measured by reviewing hospital case notes	Two weeks
Secondary	Number of patients alive at the end of the study	Measured by reviewing hospital case notes	Up to two years
Secondary	Health related quality of life	Measured on EORTC-QLQ-C30	Two weeks
Secondary	Nutritional intake	Measured by number of cartons taken by patient in 24 hours	Two weeks