Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-25 @ 4:47 PM
Study NCT ID:
NCT03150992
Status:
UNKNOWN
Last Update Posted:
2019-03-26
First Post:
2017-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EDMONd - Elemental Diet in Bowel Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D010534', 'term': 'Peritoneal Neoplasms'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005526', 'term': 'Food, Formulated'}], 'ancestors': [{'id': 'D019648', 'term': 'Foods, Specialized'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2017-04-03', 'studyFirstSubmitQcDate': '2017-05-10', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Taste acceptability of ED', 'timeFrame': 'Two weeks', 'description': '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).'}, {'measure': 'Change in incidence of vomiting', 'timeFrame': 'Two weeks', 'description': '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).'}, {'measure': 'Change in incidence of pain', 'timeFrame': 'Two weeks', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'The number of patients who can tolerate ED following presentation with IBO and can subsequently be treated with palliative chemotherapy', 'timeFrame': 'Two weeks', 'description': 'Measured by reviewing hospital case notes'}, {'measure': 'Number of patients alive at the end of the study', 'timeFrame': 'Up to two years', 'description': 'Measured by reviewing hospital case notes'}, {'measure': 'Health related quality of life', 'timeFrame': 'Two weeks', 'description': 'Measured on EORTC-QLQ-C30'}, {'measure': 'Nutritional intake', 'timeFrame': 'Two weeks', 'description': 'Measured by number of cartons taken by patient in 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Feasibility', 'Elemental Diet', 'Quality of life', 'Palliative', 'Nutrition', 'Ovarian', 'Peritoneal', 'Advanced', 'Metastatic', 'Bowel obstruction', 'Inoperable'], 'conditions': ['Ovarian Cancer', 'Ovarian Neoplasms', 'Ovarian Disease', 'Peritoneal Neoplasms', 'Peritoneal Diseases', 'Metastatic Ovarian Cancer', 'Primary Peritoneal Carcinoma', 'Abdominal Neoplasm', 'Bowel Obstruction']}, 'descriptionModule': {'briefSummary': "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", 'detailedDescription': '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 veinsÍž 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Confirmed inoperable bowel obstruction due to disseminated malignancy\n* Ability to tolerate 500ml of liquid\n* Capacity to give informed consent\n\nExclusion Criteria:\n\n* Bowel obstruction that can be managed with surgical intervention\n* Complete bowel obstruction and inability to tolerate small amount of liquid'}, 'identificationModule': {'nctId': 'NCT03150992', 'acronym': 'EDMONd', 'briefTitle': 'EDMONd - Elemental Diet in Bowel Obstruction', 'organization': {'class': 'OTHER', 'fullName': 'Royal Surrey County Hospital NHS Foundation Trust'}, 'officialTitle': 'A Feasibility Study of Elemental Diet as an Alternative to Parenteral Nutrition for Patients With Inoperable Malignant Bowel Obstruction', 'orgStudyIdInfo': {'id': '16/LO/2079'}, 'secondaryIdInfos': [{'id': '32895', 'type': 'OTHER', 'domain': 'NIHR Portfolio'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elemental 028 Extra Liquid', 'description': '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.', 'interventionNames': ['Dietary Supplement: Elemental 028 Extra Liquid']}], 'interventions': [{'name': 'Elemental 028 Extra Liquid', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Elemental Diet'], 'description': '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.', 'armGroupLabels': ['Elemental 028 Extra Liquid']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GU2 7XX', 'city': 'Guildford', 'state': 'Surrey', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Eleanor Smith', 'role': 'CONTACT', 'email': 'eleanor.smith@surrey.ac.uk', 'phone': '01483 688547'}, {'name': 'Agnieszka Michael, MBBS PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Surrey County Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'centralContacts': [{'name': 'Eleanor Smith', 'role': 'CONTACT', 'email': 'eleanor.smith@surrey.ac.uk', 'phone': '01483 688547'}], 'overallOfficials': [{'name': 'Agnieszka Michael, MBBS PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Surrey County Hospital, University of Surrey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Surrey County Hospital NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Surrey', 'class': 'OTHER'}, {'name': 'Target Ovarian Cancer', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant in Medical Oncology', 'investigatorFullName': 'Agnieszka Michael', 'investigatorAffiliation': 'Royal Surrey County Hospital NHS Foundation Trust'}}}}