EDMONd - Elemental Diet in Bowel Obstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-19

Study Completion Date

2019-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Ovarian Cancer Ovarian Neoplasms Ovarian Disease Peritoneal Neoplasms Peritoneal Diseases Metastatic Ovarian Cancer Primary Peritoneal Carcinoma Abdominal Neoplasm Bowel Obstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Elemental 028 Extra Liquid

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Elemental Diet

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Confirmed inoperable bowel obstruction due to disseminated malignancy
* Ability to tolerate 500ml of liquid
* Capacity to give informed consent