Ovarian CancerEDMONdNCT03150992
EDMONd - Elemental Diet in Bowel Obstruction
A study testing Elemental 028 Extra Liquid in people with Ovarian Cancer and Ovarian Neoplasms, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Ovarian Cancer, Ovarian Neoplasms, Ovarian Disease
- What is being tested?
- Elemental 028 Extra Liquid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jul 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Confirmed inoperable bowel obstruction due to disseminated malignancy
- Ability to tolerate 500ml of liquid
- Capacity to give informed consent
Who cannot join
- Bowel obstruction that can be managed with surgical intervention
- Complete bowel obstruction and inability to tolerate small amount of liquid
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Surrey County Hospital NHS Foundation Trust
Guildford, Surrey, GU2 7XX
Eleanor Smith, 01483 688547, eleanor.smith@surrey.ac.uk
Agnieszka Michael, MBBS PhD
About this study
Official title: A Feasibility Study of Elemental Diet as an Alternative to Parenteral Nutrition for Patients With Inoperable Malignant Bowel Obstruction
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
Read the 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.
- Conditions
- Ovarian Cancer, Ovarian Neoplasms, Ovarian Disease, Peritoneal Neoplasms, Peritoneal Diseases, Metastatic Ovarian Cancer
- Being tested
- Elemental 028 Extra Liquid
- Keywords
- Feasibility, Elemental Diet, Quality of life, Palliative, Nutrition, Ovarian, Peritoneal, Advanced, Metastatic, Bowel obstruction, Inoperable
- Medical subject headings
- Ovarian Neoplasms, Ovarian Diseases, Peritoneal Neoplasms, Peritoneal Diseases, Abdominal Neoplasms, Intestinal Obstruction, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elemental 028 Extra LiquidDietary supplement
Also called Elemental Diet
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Elemental 028 Extra Liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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
Measured by reviewing hospital case notes
Measured: Two weeks
Number of patients alive at the end of the study
Measured by reviewing hospital case notes
Measured: Up to two years
Health related quality of life
Measured on EORTC-QLQ-C30
Measured: Two weeks
Nutritional intake
Measured by number of cartons taken by patient in 24 hours
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start19 Jul 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Surrey, Target Ovarian Cancer
- Responsible party
- Principal investigator, Agnieszka Michael, Royal Surrey County Hospital NHS Foundation Trust
- Investigators
- Agnieszka Michael, MBBS PhD, Principal investigator, Royal Surrey County Hospital, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150992
- Sponsor's protocol ID
- 16/LO/2079
- Other IDs
- 32895
- Acronym
- EDMONd
- Status last verified
- Mar 2019
- First submitted
- 3 Apr 2017
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Elemental Diet as an Alternative to Parenteral Nutrition for Patients With Inoperable Malignant Bowel Obstruction
- ClinicalTrials.gov ID
- NCT03150992
- Acronym / sponsor ID
- EDMONd / 16/LO/2079
- Conditions
- Ovarian Cancer, Ovarian Neoplasms, Ovarian Disease, Peritoneal Neoplasms, Peritoneal Diseases, Metastatic Ovarian Cancer
- Keywords
- Feasibility, Elemental Diet, Quality of life, Palliative, Nutrition, Ovarian, Peritoneal, Advanced
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Surrey, Target Ovarian Cancer
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elemental 028 Extra Liquid | Experimental | Dietary Supplement: Elemental 028 Extra LiquidAll 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Confirmed inoperable bowel obstruction due to disseminated malignancy
- Ability to tolerate 500ml of liquid
- Capacity to give informed consent
Key exclusion criteria (2 listed)
- Bowel obstruction that can be managed with surgical intervention
- Complete bowel obstruction and inability to tolerate small amount of liquid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elemental 028 Extra LiquidAlso: Elemental DietA 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. | Dietary supplement | Elemental 028 Extra Liquid |
Primary outcome
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).
4 secondary outcomes
The number of patients who can tolerate ED following presentation with IBO and can subsequently be treated with palliative chemotherapy
Time frame: Two weeks
Number of patients alive at the end of the study
Time frame: Up to two years
Health related quality of life
Time frame: Two weeks
Nutritional intake
Time frame: Two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Michael, MBBS PhD principal investigator
Royal Surrey County Hospital, University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elemental 028 Extra Liquid in people with Ovarian Cancer and Ovarian Neoplasms, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleanor Smith (01483 688547, eleanor.smith@surrey.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste acceptability of ED (time frame: Two weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019; AzTrials last refreshed its copy on 26 Oct 2026.