Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT04812704
Status:
TERMINATED
Last Update Posted:
2023-04-14
First Post:
2021-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Protein Supplements in Association With Prehabilitation Program for Cancer Patients Before Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067816', 'term': 'Whey Proteins'}], 'ancestors': [{'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000067796', 'term': 'Whey'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'inclusion difficulty', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2021-03-05', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adhesion rate of the use of nutritionnel complements after exercices before surgery for cancer', 'timeFrame': '3 weeks', 'description': 'The feasibility of this outcome will be assess by the adhesion rate : (number of protein shots taken) / (number of protein shots prescribed). The adhesion will be validated if\\> 75% of the holds are respected.'}], 'secondaryOutcomes': [{'measure': 'Body composition (lean and fat mass)', 'timeFrame': 'Once at the inclusion and once the day before surgery (3 weeks)', 'description': 'Evaluated by an impedancemetry balance : pourcentage of lean and fat mass'}, {'measure': 'Muscle function', 'timeFrame': 'Once at the inclusion and once the day before surgery (3 weeks)', 'description': 'This variable will be studied by the 6-minutes walk test (meters)'}, {'measure': 'Nutritional biological markers', 'timeFrame': 'Once at the inclusion', 'description': 'These variables will be studied by: prealbumin (g/L) and albumin (g/L) measures'}, {'measure': 'Antropometric markers - height', 'timeFrame': 'Once at the inclusion and once the day before surgery (3 weeks)', 'description': 'Height (meters)'}, {'measure': 'Muscle strength', 'timeFrame': 'Once at the inclusion and once the day before surgery (3 weeks)', 'description': 'This variable will be studied by the hand grip test (kilograms)'}, {'measure': 'Antropometric markers - weight', 'timeFrame': 'Once at the inclusion and once the day before surgery (3 weeks)', 'description': 'Weight (kilograms)'}, {'measure': 'Antropometric markers - BMI', 'timeFrame': 'Once at the inclusion and once the day before surgery (3 weeks)', 'description': 'BMI (kg/m²) :weight and height will be combined to report BMI in kg/m²'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Surgery', 'Prehabilitation']}, 'descriptionModule': {'briefSummary': 'The aim of study is to analyse the feasibility of the use of nutritionnal complements after exercices before surgery for cancer.\n\nBody composition, muscle function and muscle mass will be analyse too.', 'detailedDescription': 'A prospective study will be carried out including adult patients with neoplasia who should benefit in their therapeutic strategy from oncological surgery. About fifty patients will be recruited in the oncology / surgery department at the Saint-Luc University Clinics in Brussels. Patients will be assessed at the initial consultation and after the pre-habilitation period, ie the day before the operation.\n\nDietary monitoring will be carried out in parallel with a physical and respiratory preparation program (prehabilitation) and the intake of protein nutritional supplements in the form of powder to be diluted will be carried out after each exercise session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with operable cancer\n* patient inform consent\n* min 18 years old\n* french or english speaking\n\nExclusion Criteria:\n\n* neuromuscular pathology\n* cardiorespiratory or orthopedic pathology that prevents physical activity\n* cognitive or psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT04812704', 'briefTitle': 'Protein Supplements in Association With Prehabilitation Program for Cancer Patients Before Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': "Suppléments protéinés en Association d'un Programme de préhabilitation Avant la Prise en Charge Chirurgicale d'un Cancer", 'orgStudyIdInfo': {'id': '2021/19JAN/022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutritional complement', 'description': 'A prospective study will be carried out including adult patients with neoplasia who should benefit in their therapeutic strategy from oncological surgery. About fifty patients will be recruited in the oncology / surgery department at the Saint-Luc University Clinics in Brussels. Patients will be assessed at the initial consultation and after the pre-habilitation period, ie the day before the operation.\n\nDietary monitoring will be carried out in parallel with a physical and respiratory preparation program (prehabilitation) and the intake of protein nutritional supplements in the form of powder to be diluted will be carried out after each exercise session.', 'interventionNames': ['Dietary Supplement: Whey protein']}], 'interventions': [{'name': 'Whey protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patient receive protein supplement in liquid form after each exercice session', 'armGroupLabels': ['Nutritional complement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Yannick Deswysen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Deswysen Yannick', 'investigatorAffiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}}}}