Short-term fasting versus usual diet during chemotherapy for advanced ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center interventional study will assign women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are scheduled for neoadjuvant chemotherapy to either short-term fasting around treatment or a free (usual) diet. The primary endpoint is the reduction in mean insulin levels between groups, with 27 patients per arm planned to detect a large effect (Cohen's d = 1) at 95% power and 5% significance. Secondary outcomes include effects on metabolic, endocrine, hematologic, inflammatory and tumor markers, body weight and composition, objective response rate, tolerability and toxicity, progression-free and overall survival, quality of life, and translational endpoints examining immune changes and gut microbiota. Participants will undergo serial blood testing, body composition measures, treatment response assessments, and microbiome sampling during treatment and follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• DH Tumori Femminili
  Roma, Italy Recruiting

Study contacts

• Principal investigator: Claudia Marchetti — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: claudia marchetti
• Email: claudia.marchetti@policlinicogemelli.it
• Phone: 0630158556

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.