Status:
COMPLETED
Safety, Feasibility and Metabolic Effects of the Fasting Mimicking Diet (FMD) in Cancer Patients
Lead Sponsor:
Filippo de Braud
Collaborating Sponsors:
University of Milan
Conditions:
Malignant Neoplasm
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In preclinical studies, cyclic calorie-restricted diets reduce the risk of several cancers and improve the antitumor activity of standard treatments against already established malignancies.In particu...
Detailed Description
Tumor and normal cells display differential sensitivity to nutrient and growth factor deprivation. Due to high proliferation rates, most tumor cells depend on continuous energy and metabolic replenish...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Cytologically or Histologically confirmed diagnosis of malignant neoplasm
- Capability of swallowing plant-based foods foreseen by the FMD
- Body mass index (BMI) ≥ 20 kg/m2
- Adequate bone marrow function, including:
- Hemoglobin \> 9 g/dl
- Piatelets \> 75,000/µl
- Absolute neutrophil count (ANC) \> 1,500/µl
- Creatinine \< 1.5 mg/dl or calculated creatinine clearance ≥50 mL/min
- Uric acid \< 6 mg/dl
- Fasting glucose \> 65 mg/dl
- Total bilirubin \< 2 mg/dl or \< ULN, except for patients with Gilbert syndrome
- Written informed consent according to the local Ethics Committee requirements
- Willing and ability to accomplish blood and urinary examinations according to the protocol
- Ability to maintain a daily contact (by phone or email) with the study staff for the communication of crucial clinical information, including daily body weight, blood pressure, health status and adverse events during each of the 5 days on diet
- Exclusion criteria:
- Small cell neuroendocrine carcinoma
- Unintentional weight loss ≥ 5% in the last 3-6 months
- Known HIV infection
- Pregnancy or lactation
- History of alcohol abuse
- Diagnosis of diabetes mellitus type I or type II that requires medical treatment
- Fasting glucose \> 200 mg/dl
- Clinically meaningful cardiovascular, renal or pulmonary diseases
- Current treatment with antipsychotics
Exclusion
Key Trial Info
Start Date :
February 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT03340935
Start Date
February 1 2017
End Date
July 31 2020
Last Update
August 4 2020
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133