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RECRUITING

NCT07039331

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

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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.

Official title: The Effects of Short-term Fasting Compared to Free Diet on Ovarian Cancer Patients: A 2-Arms Pilot Randomized Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-12-07

Completion Date

2026-08-01

Last Updated

2025-07-01

Healthy Volunteers

Conditions

Ovarian Cancer

Interventions

DIETARY_SUPPLEMENT

Short Term Fasting

Short Term Fasting during the first three cycles of NACT (36h before and 24h after the end of each cycle of CT).

OTHER

Free Diet

Ordinary diet during the first three cycles of NACT without any change.

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.

Locations (1)

DH Tumori Femminili

Roma, Italy