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EDMONd - Elemental Diet in Bowel Obstruction

NCT03150992UNKNOWNNAINTERVENTIONAL

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

Key Facts

Lead Sponsor

Royal Surrey County Hospital NHS Foundation Trust

Enrollment

Start Date

2017-07-19

Completion Date

2019-12-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Elemental 028 Extra Liquid

Conditions

Ovarian CancerOvarian NeoplasmsOvarian DiseasePeritoneal NeoplasmsPeritoneal DiseasesMetastatic Ovarian CancerPrimary Peritoneal CarcinomaAbdominal NeoplasmBowel Obstruction

Eligibility

Age Range

18 Years – 90 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: Two weeks

Secondary Outcomes

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

Time frame: Two weeks

Number of patients alive at the end of the study

Measured by reviewing hospital case notes

Time frame: Up to two years

Health related quality of life

Measured on EORTC-QLQ-C30

Time frame: Two weeks

Nutritional intake

Measured by number of cartons taken by patient in 24 hours

Time frame: Two weeks

Locations

Royal Surrey County Hospital NHS Foundation Trust, Guildford, United Kingdom

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.