Locally Advanced Breast CancerNCT06174259
Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients
A study testing intermittent fasting in people with Locally Advanced Breast Cancer and Intermittent Fasting, run by Menoufia University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Breast Cancer, Intermittent Fasting
- What is being tested?
- intermittent fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia university
Shibīn al Kawm, Menoufia, 32511
mary youssef, Ms, 800-555-5577 ext. +20, yoyonagy7@gmail.com
Yostena Mekhail, MD
About this study
Official title: Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients: a Prospective Randomized Controlled Trial
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.
- Being tested
- intermittent fasting
- Keywords
- locally advanced breast cancer, HR positive HER2 negative breast cancer, intermittent fasting
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent fastingOther
16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day)
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting | Experimental | 16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day) around standard neoadjuvant chemotherapy. Receives: Other: intermittent fasting |
| regular diet | No intervention | Regular diet around standard neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological response rate
Assessment of pathological response using the Miller-Payne grading system; it is a grading system from 1-5 with 5 is the best response
Measured: 6months
Secondary outcomes (6)
The percentage of patients with grade III/IV toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 6 months
Grade I/II side effects of chemotherapy
Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 6 months
Clinical response
Radiological before and after the NACT (neoadjuvant chemotherapy) using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Measured: 6months
Body composition changes (fat, muscles, water)
using Bioimpedance analysis (BIA) assessment before, 3months and at the end of NACT
Measured: 6 months
Inflammatory response to chemotherapy.
CRP level
Measured: 6 months
Long term efficacy of treatment
(DFS, OS)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yostena nagy kamel mekhail, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174259
- Sponsor's protocol ID
- 1998DRXVTF
- Status last verified
- Jan 2024
- First submitted
- 8 Dec 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be published after completing the study in peer reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06174259
- Acronym / sponsor ID
- 1998DRXVTF
- Keywords
- locally advanced breast cancer, HR positive HER2 negative breast cancer, intermittent fasting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting | Experimental | Other: intermittent fasting16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day) around standard neoadjuvant chemotherapy. |
| regular diet | No intervention | –Regular diet around standard neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intermittent fasting16/8 intermittent fasting (limiting foods and calorie-containing beverages to a set window of 8 hours per day) | Other | Intermittent fasting |
Primary outcome
pathological response rate
Time frame: 6months
Assessment of pathological response using the Miller-Payne grading system; it is a grading system from 1-5 with 5 is the best response
6 secondary outcomes
The percentage of patients with grade III/IV toxicity
Time frame: 6 months
Grade I/II side effects of chemotherapy
Time frame: 6 months
Clinical response
Time frame: 6months
Body composition changes (fat, muscles, water)
Time frame: 6 months
Inflammatory response to chemotherapy.
Time frame: 6 months
Long term efficacy of treatment
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No. Data will be published after completing the study in peer reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent fasting in people with Locally Advanced Breast Cancer and Intermittent Fasting, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yostena Mekhail, MD (800-545-5557 ext. 20+, youstena.kamel@med.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological response rate (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.