Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT03959618
Status:
COMPLETED
Last Update Posted:
2021-05-21
First Post:
2019-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous Chemotherapy and Plant-based Dietary Supplements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-20', 'studyFirstSubmitDate': '2019-05-15', 'studyFirstSubmitQcDate': '2019-05-20', 'lastUpdatePostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluate quantitatively the use of dietary supplements in patients during IV chemotherapy', 'timeFrame': '12 months', 'description': 'rate of patients taking a dietary supplement'}], 'secondaryOutcomes': [{'measure': 'Evaluate the impact of taking Desmodium between the first and last cycle of treatment', 'timeFrame': '12 months', 'description': '% of patients with hepatic cytolysis undergoing chemotherapy between the first and last treatments'}, {'measure': 'Description of dietary supplements taken', 'timeFrame': '12 months', 'description': 'Description of different types of dietary supplements'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dietary supplements', 'Desmodium', 'chemotherapy', 'breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'More and more patients report taking dietary supplements based on herbal medicine, aromatherapy, vitamintherapy,... in the course of their detoxifying anticancer chemotherapy, to stimulate the immune defenses, to relieve and/or decrease the side effects of chemo or even to act against cancer. At European level, there are between 15 and 73% of patients treated for cancer taking a dietary supplement (in particular phytotherapy) or a great heterogeneity according to the studies. However, there is still little evidence of the efficacy of these dietary supplements. A large proportion of patients do not seem to inform their doctor about the use of dietary supplements. Patients using dietary supplements most often ignore the mode of action of these products and generally say they are not informed.\n\nIn 2015, at the West Cancerology Institute (ICO), 5 patient files were analyzed taking this type of treatment in addition to chemotherapy; in 2016, 24 files; 2017, 61 patient records and this continues to progress.\n\nAt the same time, a product appears very frequently associated with cancer chemotherapy: Desmodium Adscendens, an African plant with in vitro properties of liver protector. The Desmodium contains triterpene saponins, alkaloids, flavonoids, polyphenols, and tryptamine derivatives.\n\nMorevover, several situations of patients undergoing chemotherapy and taking long-term Desmodium, with hepatic cytolyses were experienced, not explained by the usual treatments (case described in the literature).\n\nTherefore, this study will evaluate these new therapeutic modalities that are included in the intake of chemotherapy in order to better know them to improve the therapeutic taking of patients and to focus on the impact of Desmodium in association with chemotherapy.', 'detailedDescription': '* Determine the quantitative impact of the use of dietary supplements by patients with breast cancer and treated in a neo-adjuvant and/or adjuvant condition by IV chemotherapy in day hospital.\n* Determine an over-risk of disruption of liver balance in the population of patients taking Desmodium.\n* Gather a critical mass of relevant information with the objective of carrying out the evaluation and analysis of cancer care practices related to the intake of dietary supplements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of the ICO René Gauducheau taken care at day hospital for IV chemotherapy treatment of breast cancer in neoadjuvant and/or adjuvant situation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* breast cancer treated by intra-venous chemotherapy\n* inclusion at the last cycle (cure)\n* all chemotherapy cycles realised at ICO\n\nExclusion Criteria:\n\n* no breast cancer\n* metastatic breast cancer\n* not all chemotherapy cycles realised at ICO\n* patient who has not finished his chemotherapy'}, 'identificationModule': {'nctId': 'NCT03959618', 'acronym': 'CIVCAP', 'briefTitle': 'Intravenous Chemotherapy and Plant-based Dietary Supplements', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'Mono-centric, Prospective, Non-Interventional Study of Quantitative and Qualitative Analysis of Dietary Supplement Taken With Chemotherapy Treatments in Patients With Adjuvant Breast Cancer Taken Care of at the Day Hospital', 'orgStudyIdInfo': {'id': 'ICO-N-2018-12'}, 'secondaryIdInfos': [{'id': '2018-A02460-55', 'type': 'REGISTRY', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'dietary supplements group', 'description': 'dietary supplements questionary', 'interventionNames': ['Other: dietary supplements questionary']}], 'interventions': [{'name': 'dietary supplements questionary', 'type': 'OTHER', 'description': 'Patient Questionary Patient to be carried out at the last cure', 'armGroupLabels': ['dietary supplements group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': "Institut de Cancerologie de L'Ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}], 'overallOfficials': [{'name': 'Emmanuelle BOURBOULOUX, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}