Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT07015294
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2025-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Fruit- and Chaya-Based Diet on Genomic Instability and Biochemical Markers in Women With Breast Cancer Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D042822', 'term': 'Genomic Instability'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005638', 'term': 'Fruit'}], 'ancestors': [{'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2025-05-26', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genomic instability index (Comet assay)', 'timeFrame': 'Baseline (prior to first NAC cycle), at the end of Cycle 2 (approximately Day 42), and at the end of Cycle 3 (approximately Day 63); each NAC cycle is 21 days in duration.', 'description': 'Measurement of DNA damage in peripheral blood leukocytes using the Comet assay, reported as tail length and tail moment'}], 'secondaryOutcomes': [{'measure': 'Serum creatinine levels', 'timeFrame': 'Baseline (prior to first NAC cycle), at the end of Cycle 2 (approximately Day 42), and at the end of Cycle 3 (approximately Day 63); each NAC cycle is 21 days in duration.', 'description': 'To assess kidney function during NAC under different dietary conditions.'}, {'measure': 'Serum aspartate aminotransferase levels', 'timeFrame': 'Baseline (prior to first NAC cycle), at the end of Cycle 2 (approximately Day 42), and at the end of Cycle 3 (approximately Day 63); each NAC cycle is 21 days in duration.', 'description': 'To evaluate hepatic enzyme fluctuations associated with diet and chemotherapy'}, {'measure': 'Blood glucose levels', 'timeFrame': 'Baseline (prior to first NAC cycle), at the end of Cycle 2 (approximately Day 42), and at the end of Cycle 3 (approximately Day 63); each NAC cycle is 21 days in duration.', 'description': 'To evaluate glycemia fluctuations associated with diet and chemotherapy'}, {'measure': 'Hemoglobin', 'timeFrame': 'Baseline (prior to first NAC cycle), at the end of Cycle 2 (approximately Day 42), and at the end of Cycle 3 (approximately Day 63); each NAC cycle is 21 days in duration.', 'description': 'To assess hematologic stability during the intervention period.'}, {'measure': 'Serum alanine aminotransferase levels', 'timeFrame': 'Baseline (prior to first NAC cycle), at the end of Cycle 2 (approximately Day 42), and at the end of Cycle 3 (approximately Day 63); each NAC cycle is 21 days in duration.', 'description': 'To evaluate hepatic enzyme fluctuations associated with diet and chemotherapy'}, {'measure': 'Platelet counts', 'timeFrame': 'Baseline (prior to first NAC cycle), at the end of Cycle 2 (approximately Day 42), and at the end of Cycle 3 (approximately Day 63); each NAC cycle is 21 days in duration.', 'description': 'To assess hemostasis stability during the intervention period.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Cnidoscolus chayamans', 'Genomic instability'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This exploratory, non-randomized clinical study aims to evaluate the potential impact of a diet enriched with fruits and chaya (Cnidoscolus aconitifolius) infusion on genomic instability and selected biochemical parameters in women with breast cancer undergoing neoadjuvant chemotherapy (NAC). Participants are assigned to either a control group receiving a conventional diet or an experimental group receiving the modified diet. Blood samples are collected at three time points during chemotherapy: prior to the first session, after the second cycle, and after the third cycle. The study involves the analysis of genomic instability using the comet assay, along with standard hematological and biochemical testing.\n\nThe study was reviewed and approved by the Research Ethics Committee of the Graduate and Research Unit of the Faculty of Medicine at the Universidad Autónoma de Yucatán. It is being conducted between August 2022 and September 2024.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Female participants', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female participants aged 20-65 years\n* Histologically confirmed breast cancer diagnosis\n* Scheduled to undergo neoadjuvant chemotherapy\n* Ability to consume chaya infusion and fruits as part of diet\n* Provided informed consent\n\nExclusion Criteria:\n\n* Diabetes mellitus or other uncontrolled metabolic diseases\n* Severe hepatic or renal insufficiency prior to NAC\n* Allergy or intolerance to any component of the experimental diet\n* Participation in other clinical trials during the study period'}, 'identificationModule': {'nctId': 'NCT07015294', 'briefTitle': 'Effect of a Fruit- and Chaya-Based Diet on Genomic Instability and Biochemical Markers in Women With Breast Cancer Receiving Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Anahuac Mayab University'}, 'officialTitle': 'Effects of a Fruit- and Vegetable-Based Diet With Chaya Supplementation on Genomic Instability Indices and Biochemical Parameters in Breast Cancer Patients Undergoing Neoadjuvant Treatment', 'orgStudyIdInfo': {'id': '092024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diet rich in fruits and chaya infusion', 'description': 'Participants followed a diet emphasizing increased fruit consumption and daily intake of chaya infusion (prepared from Cnidoscolus chayamansa leaves), known for its potential antioxidant properties. The diet was maintained throughout neoadjuvant chemotherapy cycles', 'interventionNames': ['Dietary Supplement: Fruits and chaya infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional diet', 'description': 'Participants continued their usual dietary habits, with no specific modifications, throughout the course of neoadjuvant chemotherapy', 'interventionNames': ['Dietary Supplement: Conventional diet']}], 'interventions': [{'name': 'Fruits and chaya infusion', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Increased fruit consumption and daily intake of chaya infusion (prepared from Cnidoscolus chayamansa leaves),', 'armGroupLabels': ['Diet rich in fruits and chaya infusion']}, {'name': 'Conventional diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Usual dietary habits, with no specific modifications', 'armGroupLabels': ['Conventional diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97308', 'city': 'Mérida', 'state': 'Yucatán', 'country': 'Mexico', 'facility': 'Universidad Anahuac Mayab', 'geoPoint': {'lat': 20.967, 'lon': -89.62318}}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) that underlie the results reported in this study (including text, tables, figures, and appendices) will be made available to researchers upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anahuac Mayab University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'Elda Leonor Pacheco Pantoja', 'investigatorAffiliation': 'Anahuac Mayab University'}}}}