Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-01 @ 7:40 AM
Study NCT ID:
NCT05364359
Status:
UNKNOWN
Last Update Posted:
2022-05-06
First Post:
2022-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individual Dietary Counseling Based on Taste-tests in Patients With Hematological Cancer in Cytostatic Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2022-03-23', 'studyFirstSubmitQcDate': '2022-05-05', 'lastUpdatePostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consumption of energy as a percentage of estimated need', 'timeFrame': '6 weeks', 'description': 'difference - before and after intervention'}], 'secondaryOutcomes': [{'measure': 'Fat-free-mass and fat-mass in percent (bioimpedance measurement)', 'timeFrame': '6 weeks', 'description': 'difference - before and after intervention'}, {'measure': 'Satisfaction (measured with EROTC QLQ-C30 version 3.0)', 'timeFrame': '6 weeks', 'description': 'difference - before and after intervention. Higher scores means worse outcome. Lower scores means better outcomes.'}, {'measure': 'Hand-grip-strength (measured with a dynamometer)', 'timeFrame': '6 weeks', 'description': 'difference - before and after intervention'}, {'measure': 'Body weight', 'timeFrame': '6 weeks', 'description': 'difference - before and after intervention'}, {'measure': 'Protein intake', 'timeFrame': '6 weeks', 'description': 'difference - before and after intervention'}, {'measure': 'Burning/pain in the mouth (measured on a scale)', 'timeFrame': '6 weeks', 'description': 'difference - before and after intervention measured with Likert scale (1 to 5). Higher scores means a worse outcome. Lower scores means better outcomes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'hematological', 'malignancy'], 'conditions': ['Hematological Malignancy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate whether a simple taste-test will increase the intake of energy as part of the individual dietary counseling.', 'detailedDescription': 'The investigators will investigate the tastes (umami, bitter, salty, sweet and sour) that the patients prefers in order to increase the energy intake and reduce the risk of weight loss and loss of fat-free mass for patients with hematological cancer.\n\nThe study will be conducted as a single blinded randomized controlled trial. 40 patients will be recruited, and will be divided into two groups; the intervention group and the control group. The patients will not know which group they belong to.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Able to understand the "Participant Information" paper\n* Diagnosed with hematological cancer\n* Must be undergoing chemotherapy (at least one treatment during the study)\n* Outpatient\n* Be able to take pictures of meals (and send to the sub-investigators)\n* Be able to speak and read the danish language\n\nExclusion Criteria:\n\n* Pacemaker'}, 'identificationModule': {'nctId': 'NCT05364359', 'acronym': 'HCP', 'briefTitle': 'Individual Dietary Counseling Based on Taste-tests in Patients With Hematological Cancer in Cytostatic Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Individuel diætvejledning på Baggrund af Smagstest Hos Patienter Med hæmatologisk Cancer i Cytostatisk Behandling', 'orgStudyIdInfo': {'id': 'HCP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group', 'description': 'The patients will receive a individual dietary counseling based on the taste-test', 'interventionNames': ['Dietary Supplement: Taste-test']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard dietary counseling', 'description': 'The patients will receive a individual standard dietary counseling not based on the taste-test', 'interventionNames': ['Other: Standard care']}], 'interventions': [{'name': 'Taste-test', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Dietary counseling'], 'description': 'Patients will receive a dietary counseling based on a simple taste-test', 'armGroupLabels': ['Intervention group']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'Patients will receive a dietary counseling based on a standard dietary counseling for the patient group', 'armGroupLabels': ['Standard dietary counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Department of Hematology', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zealand University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}