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

Recruiting now · Not applicable

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT07039331

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

54

Starts

2021-12-07

Expected to finish

2026-08-01

Last updated by the study team

2025-07-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• DH Tumori Femminili — Roma, Italy (enrolling)

Full record on ClinicalTrials.gov

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