Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients
NCT ID: NCT06174259
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2023-06-01
2025-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intermittent fasting
16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day) around standard neoadjuvant chemotherapy.
intermittent fasting
16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day)
regular diet
Regular diet around standard neoadjuvant chemotherapy
No interventions assigned to this group
Interventions
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intermittent fasting
16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day)
Eligibility Criteria
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Inclusion Criteria
* Measurable disease (breast and/or lymph nodes).
* WHO performance status 0-2.
* Being overweight (BMI: 25-29.9 kg/m2) or obese (BMI: ≥30 kg/m2).
* Adequate bone marrow function : white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
* 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
* Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
* Patients must be accessible for treatment and follow-up
Exclusion Criteria
* Diabetes Mellitus.
* Pregnancy or lactating
* Any metabolic disorders that may affect gluconeogenesis or adaptation to fasting periods.
* Previous malignancy.
* Using weight loss medication.
18 Years
FEMALE
No
Sponsors
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Menoufia University
OTHER
Responsible Party
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yostena nagy kamel mekhail
Dr
Locations
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Menoufia university
Shibīn al Kawm, Menoufia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1998DRXVTF
Identifier Type: -
Identifier Source: org_study_id
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