NCT06610565 Fasting-mimicking Diet Intervention on Side Effects of Aromatase Inhibitors Treatment in Patients With Breast Cancer
| NCT ID | NCT06610565 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Institute of Oncology |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-04-01 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: * 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) * Ongoing treatment with aromatase inhibitors (at least six months of drug exposure) * Adequate renal, hepatic, and hematopoietic function * Written and informed consent for biomaterial submission and participation in the clinical trial * Compliance with treatment and follow up protocol * No other investigational agent may be administered concurrently to patients enrolled in this trial * Patients with skeletal pain are eligible if bone scan and/or RX examination fails to disclose metastatic disease * The interval between the onset of systemic adjuvant therapy with AIs and the randomization should be at least 6 months * Patient is accessible geographically for follow-up and must be able to provide dietary data via telephone recalls * Must be medical
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