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 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2021-12-07 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Claudia Marchetti
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT07039331 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07039331 currently recruiting?
Yes, NCT07039331 is actively recruiting participants. Contact the research team at claudia.marchetti@policlinicogemelli.it for enrollment information.
Where is the NCT07039331 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07039331 clinical trial?
NCT07039331 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Claudia Marchetti at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 54 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.