EDMONd - Elemental Diet in Bowel Obstruction (EDMONd)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03150992|
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : March 26, 2019
|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|
|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|
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
- 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).
- 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).
- 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).
- 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
- Number of patients alive at the end of the study [ Time Frame: Up to two years ]Measured by reviewing hospital case notes
- Health related quality of life [ Time Frame: Two weeks ]Measured on EORTC-QLQ-C30
- Nutritional intake [ Time Frame: Two weeks ]Measured by number of cartons taken by patient in 24 hours
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
|Contact: Eleanor Smith||01483 email@example.com|
|Royal Surrey County Hospital NHS Foundation Trust||Recruiting|
|Guildford, Surrey, United Kingdom, GU2 7XX|
|Contact: Eleanor Smith 01483 688547 firstname.lastname@example.org|
|Principal Investigator: Agnieszka Michael, MBBS PhD|
|Principal Investigator:||Agnieszka Michael, MBBS PhD||Royal Surrey County Hospital, University of Surrey|