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

Summary

The primary endpoint of the study is the reduction of insulin levels between the two groups. Using the Student's t-test, while maintaining the study power at 95% and the significance level at 5%, a sample of 27+27 patients will allow the identification of differences in terms of Cohen's d equal to 1.

Eligibility

Inclusion Criteria:

* 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

Exclusion Criteria

* 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
* Pregnancy or lactating;
* Significant food allergies which would make the subject unable to consume the food provided;
* History of or manifest eating disorder;
* Impaired physical mobility.

Conditions2

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