EDMONd - Elemental Diet in Bowel Obstruction

Last updated: March 25, 2019
Sponsor: Royal Surrey County Hospital NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Vaginal Cancer

Metastatic Cancer

Treatment

N/A

Clinical Study ID

NCT03150992
16/LO/2079
32895
  • Ages 18-90
  • Female

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Bowel obstruction that can be managed with surgical intervention

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

Study Design

Total Participants: 34
Study Start date:
July 19, 2017
Estimated Completion Date:
December 31, 2019

Study 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.

Connect with a study center

  • Royal Surrey County Hospital NHS Foundation Trust

    Guildford, Surrey GU2 7XX
    United Kingdom

    Active - Recruiting

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