Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT06174259
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2023-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093763', 'term': 'Intermittent Fasting'}], 'ancestors': [{'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2023-12-08', 'studyFirstSubmitQcDate': '2023-12-08', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pathological response rate', 'timeFrame': '6months', 'description': 'Assessment of pathological response using the Miller-Payne grading system; it is a grading system from 1-5 with 5 is the best response'}], 'secondaryOutcomes': [{'measure': 'The percentage of patients with grade III/IV toxicity', 'timeFrame': '6 months', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) v5.0'}, {'measure': 'Grade I/II side effects of chemotherapy', 'timeFrame': '6 months', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) v5.0'}, {'measure': 'Clinical response', 'timeFrame': '6months', 'description': 'Radiological before and after the NACT (neoadjuvant chemotherapy) using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1'}, {'measure': 'Body composition changes (fat, muscles, water)', 'timeFrame': '6 months', 'description': 'using Bioimpedance analysis (BIA) assessment before, 3months and at the end of NACT'}, {'measure': 'Inflammatory response to chemotherapy.', 'timeFrame': '6 months', 'description': 'CRP level'}, {'measure': 'Long term efficacy of treatment', 'timeFrame': '5 years', 'description': '(DFS, OS)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['locally advanced breast cancer', 'HR positive HER2 negative breast cancer', 'intermittent fasting'], 'conditions': ['Locally Advanced Breast Cancer', 'Intermittent Fasting']}, 'descriptionModule': {'briefSummary': 'Breast cancer is the most common cancer type among women in Egypt and world. Preclinical studies show fasting reduces growth factors and modulates nutrient sensing systems, protecting normal cells against chemotherapy. However, cancer cells are not protected due to Differential Stress Resistance (DSR), making them more vulnerable to chemotherapeutics. This study aims to evaluate intermittent fasting impact on neoadjuvant chemotherapy in breast cancer patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients with stage II or III (cT1cN+ or ≥T2 any cN, cM0) breast cancer. - Planned to receive standard neoadjuvant chemotherapy.\n* Measurable disease (breast and/or lymph nodes).\n* WHO performance status 0-2.\n* Being overweight (BMI: 25-29.9 kg/m2) or obese (BMI: ≥30 kg/m2).\n* Adequate bone marrow function : white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l\n* Adequate liver function: bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL\n* Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min\n* Patients must be accessible for treatment and follow-up\n\nExclusion Criteria:\n\n* Serious diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias\n* Diabetes Mellitus.\n* Pregnancy or lactating\n* Any metabolic disorders that may affect gluconeogenesis or adaptation to fasting periods.\n* Previous malignancy.\n* Using weight loss medication.'}, 'identificationModule': {'nctId': 'NCT06174259', 'briefTitle': 'Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients: a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1998DRXVTF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intermittent fasting', 'description': '16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day) around standard neoadjuvant chemotherapy.', 'interventionNames': ['Other: intermittent fasting']}, {'type': 'NO_INTERVENTION', 'label': 'regular diet', 'description': 'Regular diet around standard neoadjuvant chemotherapy'}], 'interventions': [{'name': 'intermittent fasting', 'type': 'OTHER', 'description': '16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day)', 'armGroupLabels': ['Intermittent fasting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32511', 'city': 'Shibīn al Kawm', 'state': 'Menoufia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mary youssef, Ms', 'role': 'CONTACT', 'email': 'yoyonagy7@gmail.com', 'phone': '800-555-5577', 'phoneExt': '+20'}, {'name': 'Yostena Mekhail, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eman Abdelrazek, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Menoufia university', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}], 'centralContacts': [{'name': 'Yostena Mekhail, MD', 'role': 'CONTACT', 'email': 'youstena.kamel@med.menofia.edu.eg', 'phone': '800-545-5557', 'phoneExt': '20+'}, {'name': 'Eman Abdelrazek, MD', 'role': 'CONTACT', 'email': 'eman.tawfeek@med.menofia.edu.eg', 'phone': '800-543-5556'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be published after completing the study in peer reviewed journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'yostena nagy kamel mekhail', 'investigatorAffiliation': 'Menoufia University'}}}}