RecruitingNot ApplicableNCT06610565

Fasting-mimicking Diet Intervention on Side Effects of Aromatase Inhibitors Treatment in Patients With Breast Cancer

Fasting-mimicking Diet: A Randomized Trial on Feasibility, Safety and Effects of Multicycle Dietary Intervention on Side Effects of Aromatase Inhibitors Treatment in Post-menopausal Patients With Breast Cancer


Sponsor

European Institute of Oncology

Enrollment

60 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary endpoint of this study is to determine whether cycles of short term FMD exposure to a fasting-mimicking diet is effective in reducing total cholesterol levels.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a fasting-mimicking diet — a temporary, low-calorie eating plan that makes the body think it is fasting — can reduce the side effects of aromatase inhibitor medications used in breast cancer treatment. These side effects often include joint pain, bone loss, and high cholesterol. The diet would be done in cycles alongside ongoing medication. **You may be eligible if...** - You are 18 years or older with early-stage, hormone receptor-positive breast cancer - You are currently taking aromatase inhibitors (for at least 6 months) - You have elevated cholesterol (total cholesterol over 200 mg/dL) - Your overall health allows safe participation **You may NOT be eligible if...** - You have evidence of cancer spread (metastatic disease) - You are currently on other investigational treatments - You have inadequate kidney, liver, or blood function - You have active bone metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTFASTING-MIMICKING DIET PROGRAM

Nutritional intervention via fasting-mimicking diet. Patients receiving adjuvant therapy with aromatase inhibitors will be randomized 1:1 into two arms: one intervention, where will receive nutritional counseling and the study diet for 5 days each month for 6 months,and a control one, where they will receive only nutritional counseling.


Locations(1)

IEO

Milan, Italy, Italy

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NCT06610565


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