NCT07039331 Short-term Fasting Compared to Free Diet on Ovarian Cancer Patients
| NCT ID | NCT07039331 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2021-12-07 |
| Primary Completion | 2026-04-01 |
Trial Parameters
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Brief 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 Criteria
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 requir
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