Clinical trial NCT03150992: EDMONd - Elemental Diet in Bowel Obstruction
Official title: A Feasibility Study of Elemental Diet as an Alternative to Parenteral Nutrition for Patients With Inoperable Malignant Bowel Obstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Cancer
Ovarian Neoplasms
Ovarian Disease
Peritoneal Neoplasms
Peritoneal Diseases
Metastatic Ovarian Cancer
Primary Peritoneal Carcinoma
Abdominal Neoplasm
Bowel Obstruction
Keywords: Feasibility
Elemental Diet
Quality of life
Palliative
Nutrition
Ovarian
Peritoneal
Advanced
Metastatic
Bowel obstruction
Inoperable
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Surrey
name: Target Ovarian Cancer
First posted: 2017-05-12
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Taste acceptability of ED
timeFrame: Two weeks
measure: Change in incidence of vomiting
timeFrame: Two weeks
measure: Change in incidence of pain
timeFrame: Two weeks
Secondary outcomes:
measure: The number of patients who can tolerate ED following presentation with IBO and can subsequently be treated with palliative chemotherapy
timeFrame: Two weeks
measure: Number of patients alive at the end of the study
timeFrame: Up to two years
measure: Health related quality of life
timeFrame: Two weeks
measure: Nutritional intake
timeFrame: Two weeks
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Surrey County Hospital, University of Surrey
name: Agnieszka Michael, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References: