Short-term Fasting Compared to Free Diet on Ovarian Cancer Patients

Other illness

• No other invasive malignancy within the past 5 years;
• Diabetes mellitus;
• myocardial infarction, stroke or pulmonary embolism within the last 3 months;
• Electrocardiogram (ECG) demonstrating clinically significant arrhythmias that are not adequately medically managed (Note: subjects with chronic atrial arrhythmia, ie, atrial fibrillation or paroxysmal supraventricular tachycardia \[SVT\], are eligible)
• Active serious systemic disease, including active bacterial or fungal infection
• Active viral hepatitis or active human immunodeficiency virus (HIV) infection. Asymptomatic positive serology is not exclusionary
• heart failure ≥III NYHA
• Significant food allergies which would make the subject unable to consume the food provided;
• History of or manifest eating disorder;

Other

• Pregnancy or lactating;
• Impaired physical mobility.

• Female, aged 18 years or older;
• Histologically or cytologically documented invasive epithelial OC, primary peritoneal carcinoma, or fallopian tube cancer not suitable for primary cytoreduction, but requiring NACT;
• FIGO Stage III-IV;
• No previous treatment for EOC;
• BMI (Body Mass Index) ≥19 kg/m2;
• ECOG (Eastern Cooperative Oncology Group) performance status 0-2;
• Anticipated life expectancy of \>3 months;
• Adequate organ functions:
  • Hematopoietic; Absolute neutrophil count ≥ 1,500/mm\^3; Platelet count ≥ 100,000/mm\^3; Hemoglobin ≥ 9 g/Dl
  • Hepatic; AST and ALT ≤ 2.5 times upper limit of normal (ULN)\* ; Alkaline Phosphatase ≤ 2.5 times ULN\* ; Bilirubin ≤ 1.5 times ULN NOTE: \* ≤ 3 times ULN if liver metastases are present
  • Renal: Creatinine Clearance ≥ 45 ml/min or Serum Creatinine ≤1.5 x ULN
  • Serum Albumin \>2.5 g/dl;
• Patients must be accessible for treatment and follow-up;
• Written informed consent according to the local Ethics Committee requirements
• Patients with child-bearing potential using (or willing to use) effective contraception during treatment and 3 months ahead unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically
• Evidence of not pregnancy status as documented by a negative beta-human chorionic gonadotropin (ß-hCG) test