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Trial record 16 of 34 for:    "Ovarian Epithelial Cancer" | "Micronutrients"

EDMONd - Elemental Diet in Bowel Obstruction (EDMONd)

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ClinicalTrials.gov Identifier: NCT03150992
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : March 26, 2019
Sponsor:
Collaborators:
University of Surrey
Target Ovarian Cancer
Information provided by (Responsible Party):
Agnieszka Michael, Royal Surrey County Hospital NHS Foundation Trust

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Ovarian Neoplasms Ovarian Disease Peritoneal Neoplasms Peritoneal Diseases Metastatic Ovarian Cancer Primary Peritoneal Carcinoma Abdominal Neoplasm Bowel Obstruction Dietary Supplement: Elemental 028 Extra Liquid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Feasibility Study of Elemental Diet as an Alternative to Parenteral Nutrition for Patients With Inoperable Malignant Bowel Obstruction
Actual Study Start Date : July 19, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: 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.
Dietary Supplement: 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.
Other Name: Elemental Diet




Primary Outcome Measures :
  1. Taste acceptability of ED [ Time Frame: Two weeks ]
    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).

  2. Change in incidence of vomiting [ Time Frame: Two weeks ]
    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).

  3. Change in incidence of pain [ Time Frame: Two weeks ]
    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).


Secondary Outcome Measures :
  1. The number of patients who can tolerate ED following presentation with IBO and can subsequently be treated with palliative chemotherapy [ Time Frame: Two weeks ]
    Measured by reviewing hospital case notes

  2. Number of patients alive at the end of the study [ Time Frame: Up to two years ]
    Measured by reviewing hospital case notes

  3. Health related quality of life [ Time Frame: Two weeks ]
    Measured on EORTC-QLQ-C30

  4. Nutritional intake [ Time Frame: Two weeks ]
    Measured by number of cartons taken by patient in 24 hours



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03150992


Contacts
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Contact: Eleanor Smith 01483 688547 eleanor.smith@surrey.ac.uk

Locations
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United Kingdom
Royal Surrey County Hospital NHS Foundation Trust Recruiting
Guildford, Surrey, United Kingdom, GU2 7XX
Contact: Eleanor Smith    01483 688547    eleanor.smith@surrey.ac.uk   
Principal Investigator: Agnieszka Michael, MBBS PhD         
Sponsors and Collaborators
Royal Surrey County Hospital NHS Foundation Trust
University of Surrey
Target Ovarian Cancer
Investigators
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Principal Investigator: Agnieszka Michael, MBBS PhD Royal Surrey County Hospital, University of Surrey

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Responsible Party: Agnieszka Michael, Consultant in Medical Oncology, Royal Surrey County Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03150992     History of Changes
Other Study ID Numbers: 16/LO/2079
32895 ( Other Identifier: NIHR Portfolio )
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Agnieszka Michael, Royal Surrey County Hospital NHS Foundation Trust:
Feasibility
Elemental Diet
Quality of life
Palliative
Nutrition
Ovarian
Peritoneal
Advanced
Metastatic
Bowel obstruction
Inoperable

Additional relevant MeSH terms:
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Neoplasms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Intestinal Obstruction
Peritoneal Neoplasms
Ovarian Diseases
Abdominal Neoplasms
Peritoneal Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Digestive System Neoplasms