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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEuropean Institute of Oncology

About this trial

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 criteria

Qualifiers

Age ≥ 18 years

WHO performance status score 0-2

Early stage breast cancer, ER positive, receiving an adjuvant endocrine treatment with aromatase inhibitor

Hypercholesterolemic (total cholesterol >200mg/dL)

Disqualifiers

Underweight (BMI < 18.5 kg/m2)

Current or past eating disorders identified with the SCOFF Questionnaire (Useful Eating Disorder screening questions) [19]

Malnutrition Universal Screening Tool (MUST). It considers body mass index, weight change and acute disease effect equally and determines a malnutrition risk score. A score ≥1 identify a patient at moderate risk of malnutrition;

Treatment with any investigational or non-registered drug other than the study product(s) within 30 days preceding the first dose of study product, or planned use during the study period

Trial design

Treatments tested in this trial

  • FASTING-MIMICKING DIET PROGRAM

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators