Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT04899505
Status:
COMPLETED
Last Update Posted:
2025-05-16
First Post:
2021-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Chemotherapy on Body Odor in Adolescents and Young Adults in Oncology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2021-05-19', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of the development of unpleasant body odors in AYA oncology patients', 'timeFrame': '8 months', 'description': 'Percentage of patients reporting discomfort with unpleasant body odor that occurred during their treatment. This percentage will be calculated from the response to item Q1 of the patient questionnaire during the fourth course of chemotherapy in the AJA oncology department'}], 'secondaryOutcomes': [{'measure': 'Qualification of the smell and the discomfort felt', 'timeFrame': '8 months', 'description': 'Answers to the investigation intended for patients for the appearance of the smell with different proposals like sweating, urine, breath etc. (Q2), its qualifier with different proposals like desagreable, infective, nauseating, etc…(Q3) and the discomfort observed for themselves or for those around them (Q8)'}, {'measure': 'Quantification of the discomfort and the impact on quality of life', 'timeFrame': '8 months', 'description': 'Answers to the investigation intended for patients to assess the intensity of the smell with a scale (0= no smell and 10 = strong smell) (Q4), its daily impact with a scale (0=no impact and 10= high impact) (Q7) and solutions that can reduce smell with different proposals like perfume, cream, essential oil (Q9)'}, {'measure': 'Identify possible causes of the appearance of these new body odors', 'timeFrame': '8 months', 'description': "Answers to the investigation for patients to assess the link between smell and drug treatment with different proposals like treatment, hospital's food or hospital cleaning product (Q5 and Q6)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor, Adult', 'Solid Tumor, Childhood', 'Chemotherapy Effect']}, 'descriptionModule': {'briefSummary': 'The appearance of unpleasant body odors in adolescent Young adult (aya) wille be evaluated undergoing chemotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients aged between 15 and 25 years with solid tumors', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 15 and 25 years;\n* New patients treated at the Curie Institute and hospitalized in the AJA oncology department;\n* Patient undergoing chemotherapy administered intravenously;\n* Solid tumors.\n\nExclusion Criteria:\n\n* Patient undergoing oral chemotherapy;\n* Persons deprived of their liberty or under guardianship (including guardianship);\n* Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.'}, 'identificationModule': {'nctId': 'NCT04899505', 'acronym': 'ODORAJA', 'briefTitle': 'Evaluation of the Impact of Chemotherapy on Body Odor in Adolescents and Young Adults in Oncology', 'organization': {'class': 'OTHER', 'fullName': 'Institut Curie'}, 'officialTitle': 'ODORAJA:Evaluation of the Impact of Chemotherapy on Body Odor in Adolescents and Young Adults in Oncology', 'orgStudyIdInfo': {'id': 'IC 2021-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Evaluation on appearance of unpleasant body odors', 'description': 'Incidence of the development of unpleasant body odors in AYA oncology patients', 'interventionNames': ['Other: Evaluation on appearance of unpleasant body odors']}], 'interventions': [{'name': 'Evaluation on appearance of unpleasant body odors', 'type': 'OTHER', 'description': 'Percentage of patients reporting discomfort with unpleasant body odor that occurred during their treatment. This percentage will be calculated from the response to item Q1 of the patient questionnaire during the fourth course of chemotherapy in the AJA oncology department.', 'armGroupLabels': ['Evaluation on appearance of unpleasant body odors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Curie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}