Actively Recruiting
Short-term Fasting Compared to Free Diet on Ovarian Cancer Patients
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-07-01
54
Participants Needed
1
Research Sites
242 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Short-term Fasting Compared to Free Diet on Ovarian Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, aged 18 years or older
- Diagnosed with invasive epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer requiring neoadjuvant chemotherapy
- Cancer stage FIGO III-IV
- No prior treatment for epithelial ovarian cancer
- Body Mass Index (BMI) of 19 kg/m2 or higher
- ECOG performance status between 0 and 2
- Expected to live more than 3 months
- Adequate organ function including hematopoietic, hepatic, renal, and serum albumin levels
- Accessible for treatment and follow-up
- Provide written informed consent
- Use effective contraception during treatment and for 3 months after if of childbearing potential, or be postmenopausal or surgically sterilized
- Negative pregnancy test (beta-human chorionic gonadotropin)
You will not qualify if you...
- Any other invasive cancer within the last 5 years
- Diabetes mellitus
- Heart attack, stroke, or pulmonary embolism within the previous 3 months
- ECG showing significant uncontrolled arrhythmias (except chronic atrial arrhythmia)
- Serious active infections or systemic diseases
- Active viral hepatitis or active HIV infection (asymptomatic positive tests allowed)
- Heart failure classified as NYHA III or higher
- Pregnant or breastfeeding
- Severe food allergies preventing study diet
- History or current eating disorders
- Limited physical mobility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
DH Tumori Femminili
Roma, Italy
Actively Recruiting
Research Team
C
claudia marchetti
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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