Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients

NCT ID: NCT06174259

Last Updated: 2024-02-01

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Locally Advanced Breast Cancer Intermittent Fasting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

intermittent fasting

Intervention Type OTHER

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

Group Type NO_INTERVENTION

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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female patients with stage II or III (cT1cN+ or ≥T2 any cN, cM0) breast cancer. - Planned to receive standard neoadjuvant chemotherapy.
* 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

* Serious diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
* Diabetes Mellitus.
* Pregnancy or lactating
* Any metabolic disorders that may affect gluconeogenesis or adaptation to fasting periods.
* Previous malignancy.
* Using weight loss medication.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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yostena nagy kamel mekhail

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Menoufia university

Shibīn al Kawm, Menoufia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Yostena Mekhail, MD

Role: CONTACT

800-545-5557 ext. 20+

Eman Abdelrazek, MD

Role: CONTACT

800-543-5556

Facility Contacts

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mary youssef, Ms

Role: primary

800-555-5577 ext. +20

Other Identifiers

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1998DRXVTF

Identifier Type: -

Identifier Source: org_study_id

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