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

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

This study will test whether short-term fasting around neoadjuvant chemotherapy lowers insulin and influences treatment response in women with advanced ovarian cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Academic / other)
• Locations: 1 site (Roma)
• Trial ID: NCT07039331 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Women aged 18 or older with newly diagnosed FIGO stage III–IV epithelial ovarian, fallopian tube, or primary peritoneal cancer planned for neoadjuvant chemotherapy, BMI ≥19, ECOG 0–2, and adequate organ function are eligible.

Not a fit: Patients with prior treatment for ovarian cancer, BMI under 19, poor organ function, ECOG performance status >2, or anticipated life expectancy ≤3 months are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, short-term fasting could lower insulin and related growth factors and possibly improve chemotherapy tolerability or response for women receiving neoadjuvant therapy.

How similar studies have performed: Early small clinical and preclinical studies in various cancers have suggested metabolic and tolerability benefits from short-term fasting or fasting-mimicking diets, but robust evidence in ovarian cancer is limited.

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.

Where this trial is running

Roma

• DH Tumori Femminili — Roma, Italy (Recruiting)

Study contacts

• Principal investigator: Claudia Marchetti — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: claudia marchetti

Conditions Ovarian Cancer