Study on Time-Restricted Eating and Metformin for Patients with Invasive Breast Cancer or Ductal Carcinoma In Situ

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for certain types of breast cancer. The diseases being studied are invasive breast cancer and ductal carcinoma in situ. The treatment involves a combination of a medication called Metformin Hydrochloride, which is commonly used to manage blood sugar levels, and a practice known as time-restricted eating, where participants fast for at least 16 hours overnight.

The purpose of the study is to understand how this combination affects cancer cells. Participants will be randomly assigned to either the treatment group or a control group. The study will begin with a biopsy, which is a procedure to take a small sample of tissue from the breast cancer. After the treatment period, which lasts up to 42 days, participants will undergo surgery to remove the cancer. The researchers will compare the cancer tissue from before and after the treatment to see if there are any changes.

Throughout the study, the safety of the treatment will be closely monitored, especially in the first group of participants. The researchers are particularly interested in any side effects that might occur, such as low blood sugar levels or other significant reactions. This study aims to provide valuable insights into whether this combination of Metformin and time-restricted eating can be a safe and effective approach for treating certain types of breast cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, health status, and type of breast cancer.

Participants must agree to use contraception if of child-bearing potential and provide informed consent.

2 treatment initiation

The treatment involves taking metformin hydrochloride in the form of a prolonged-release tablet called Glucophage Unidie 750 mg.

The medication is taken orally, and the dosage and frequency are determined by the study protocol.

3 dietary intervention

Participants are required to follow a dietary intervention involving prolonged nightly fasting of at least 16 hours.

This dietary regimen is combined with the medication to assess its effects on cancer tissue.

4 monitoring and assessments

Regular monitoring is conducted to assess the safety of the treatment, focusing on any adverse effects.

The primary objective is to evaluate changes in cancer tissue before and after treatment, specifically looking at the Ki67 labeling index, a marker used to measure cell proliferation.

5 completion of treatment

The study concludes with a surgical procedure to obtain a post-treatment specimen for analysis.

The results are compared to pre-treatment data to determine the effectiveness of the intervention.

Who Can Join the Study?

  • Women with a confirmed diagnosis of ER+ve (estrogen receptor positive) and/or PgR+ve (progesterone receptor positive) breast cancer that is operable and suitable for surgery. This includes certain types of breast cancer like HER2+ve (human epidermal growth factor receptor 2 positive) and DCIS (ductal carcinoma in situ).
  • Must be 18 years or older.
  • Have an ECOG performance status of 0 or 1, which means the person is fully active or has some symptoms but can still carry out light work. This is similar to a Karnofsky score of 70% or higher, indicating the ability to care for oneself.
  • Must have normal function of organs and bone marrow, which includes:
    • Leukocytes (white blood cells) count of at least 3,000 per microliter.
    • Absolute neutrophil count (a type of white blood cell) of at least 1,500 per microliter.
    • Platelets (cells that help with blood clotting) count of at least 100,000 per microliter.
    • AST/ALT (liver enzymes) levels no more than 1.5 times the normal upper limit.
    • Creatinine clearance (a measure of kidney function) greater than 45 mL/min, estimated using the Cockcroft-Gault formula.
  • Women who can have children must agree to use contraception (methods to prevent pregnancy) or practice abstinence during the study. If a participant becomes pregnant or thinks she might be pregnant, she must inform her study doctor immediately.
  • Must be able to understand and willing to sign a written informed consent document, which means agreeing to participate in the study after being informed about it.

Who Cannot Join the Study?

  • Patients who do not have luminal invasive breast cancer or ductal carcinoma in situ. These are specific types of breast cancer.
  • Patients who are not female, as the study is only for women.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who have any medical condition or situation that the study team believes would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Ente Ospedaliero Ospedali Galliera Di Genova Genoa Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
04.04.2023

Trial locations

Investigated drugs:

Metformin is a medication commonly used to manage blood sugar levels in people with type 2 diabetes. In this clinical trial, it is being used to study its effects on breast cancer tissue, specifically looking at changes in cancer cell growth markers before and after treatment. The trial aims to see if Metformin, when combined with a specific eating pattern, can influence cancer cell activity.

Time Restricted Eating involves limiting the hours during which food is consumed each day. In this trial, participants are asked to fast for at least 16 hours overnight. This approach is being tested to see if it can enhance the effects of Metformin on breast cancer cells, potentially slowing down their growth or reducing their activity.

Invasive Breast Cancer – This type of breast cancer occurs when cancer cells spread beyond the ducts or lobules into the surrounding breast tissue. It can be classified based on hormone receptor status, such as estrogen receptor-positive (ER+) or progesterone receptor-positive (PgR+). The disease progresses as cancer cells invade nearby tissues and potentially spread to other parts of the body through the lymphatic system or bloodstream. Early stages may not cause noticeable symptoms, but as it advances, it can lead to changes in breast shape, size, or skin texture. Regular monitoring and medical evaluations are crucial for understanding its progression.

Ductal Carcinoma In Situ (DCIS) – This is a non-invasive form of breast cancer where abnormal cells are found in the lining of a breast duct but have not spread outside the duct. It is considered the earliest form of breast cancer and is sometimes referred to as stage 0. DCIS itself does not typically cause symptoms, but it can be detected through mammograms as microcalcifications. If left untreated, it may progress to invasive breast cancer, where cancer cells break through the duct walls and invade surrounding tissue. Monitoring and early detection are key to managing this condition effectively.

Trial ID:
2024-518402-40-00
NCT ID:
NCT05023967
Trial Phase:
Therapeutic exploratory (Phase II)

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