EDMONd - Elemental Diet in Bowel Obstruction (EDMONd)

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

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

Study Overview

• Status: Unknown
• Conditions: Peritoneal Diseases; Ovarian Neoplasms; Peritoneal Neoplasms; Ovarian Cancer; Abdominal Neoplasm; Bowel Obstruction; Primary Peritoneal Carcinoma; Metastatic Ovarian Cancer; Ovarian Disease
• Intervention / Treatment: Dietary supplement: Elemental 028 Extra Liquid

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7XX
      • Recruiting
      • Royal Surrey County Hospital NHS Foundation Trust
      • Contact: Eleanor Smith; Phone Number: 01483 688547; Email: eleanor.smith@surrey.ac.uk
      • Principal Investigator: Agnieszka Michael, MBBS PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Elemental 028 Extra Liquid; All patients will be assessed and given an individual plan for Elemental Diet (ED) introduction. The actual amount of ED prescribed will depend on the tolerance and palatability and not nutritional status. The recommendation of a minimum of 2 cartons of ED will be drunk orally by patients, along with other clear fluids only. Following introduction of ED, patients will be discharged from hospital (if applicable) and followed up for 2 weeks. They will have a telephone follow-up assessment once a week for 2 weeks. All other assessments will follow the standard of care. During the follow-up patients will be assessed using the Memorial Symptom Assessment Scale (MSAS) and will be asked to complete a nutritional diary every day and a quality of life questionnaire at several time points.

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.; Other Names: Elemental Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of patients alive at the end of the study	Measured by reviewing hospital case notes	Up to two years
Health related quality of life	Measured on EORTC-QLQ-C30	Two weeks
Nutritional intake	Measured by number of cartons taken by patient in 24 hours	Two weeks

Collaborators and Investigators

• Sponsor: Royal Surrey County Hospital NHS Foundation Trust
• Collaborators: University of Surrey; Target Ovarian Cancer
• Investigators: Principal Investigator: Agnieszka Michael, MBBS PhD, Royal Surrey County Hospital, University of Surrey

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 19, 2017
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (ACTUAL): May 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Feasibility; Quality of life; Nutrition; Advanced; Metastatic; Inoperable; Ovarian; Peritoneal; Palliative; Bowel obstruction; Elemental Diet
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Adnexal Diseases; Gonadal Disorders; Digestive System Neoplasms; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Intestinal Diseases; Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Ovarian Epithelial; Abdominal Neoplasms; Ovarian Diseases; Intestinal Obstruction; Peritoneal Diseases
• Other Study ID Numbers: 16/LO/2079; 32895 (OTHER: NIHR Portfolio)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No