EDMONd - Elemental Diet in Bowel Obstruction

NCT03150992 | Unknown

• 2 other identifiers: 16/LO/207932895
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• The number of patients who can tolerate ED following presentation with IBO and can subsequently be treated with palliative chemotherapy

  Two weeks

• Number of patients alive at the end of the study

  Up to two years

• Health related quality of life

  Two weeks

• Nutritional intake

  Two weeks

Study Arms (1)

Elemental 028 Extra Liquid

EXPERIMENTAL

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

Interventions

Elemental 028 Extra Liquid 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.

Also known as: Elemental Diet

Elemental 028 Extra Liquid

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Bowel obstruction that can be managed with surgical intervention
• Complete bowel obstruction and inability to tolerate small amount of liquid

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead
• University of Surrey: collaborator
• Target Ovarian Cancer: collaborator

Study Sites (1)

Royal Surrey County Hospital NHS Foundation Trust

Guildford, Surrey, GU2 7XX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Ovarian Diseases; Peritoneal Neoplasms; Peritoneal Diseases; Abdominal Neoplasms; Intestinal Obstruction; Neoplasm Metastasis

Interventions

Food, Formulated

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Digestive System Neoplasms; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Foods, Specialized; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Agnieszka Michael, MBBS PhD

  Royal Surrey County Hospital, University of Surrey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleanor Smith

CONTACT

01483 688547; eleanor.smith@surrey.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Medical Oncology

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: May 12, 2017
• Study Start: July 19, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)