Safety, Feasibility and Metabolic Effects of the Fasting Mimicking Diet (FMD) in Cancer Patients

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 particular, the fasting mimicking diet (FMD), a plant-based, calorie-restricted, low carbohydrate, low-protein diet to be repeated cyclically every 3-4 weeks, enhances the antitumor activity of cytotoxic chemotherapy, while contemporarily protecting healthy tissues and stimulating antitumor immunity. Most of these effects are likely mediated by the reduction of blood glycemia and growth factors, such as insulin and insulin-like growth factor 1 (IGF-1). When administered to healthy volunteers, cyclic FMD has been shown to be safe and capable of reducing risk factors for different chronic diseases. However, the effects of the FMD in cancer patient populations have not been evaluated so far. This study aims to assess the safety, feasibility and metabolic effects of the FMD in cancer patients treated with different standard antitumor therapies. Patients with any malignancy, with the exception of small cell neuroendocrine tumors, will be considered for enrollment in this study. The FMD will be administered up to a maximum of 8 consecutive cycles in combination with standard adjuvant treatments or therapies for advanced disease.

Sex

All

Minimum age

18 Years

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:

  1. Hemoglobin \> 9 g/dl
  2. Piatelets \> 75,000/µl
  3. 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

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