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Compares treatment options for Ovarian Cancer
Official title Short-term Fasting Compared to Free Diet on Ovarian Cancer Patients
ClinicalTrials.gov ID: NCT07039331
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- FIGO Stage III-IV;
- No previous treatment for EOC;
- BMI (Body Mass Index) ≥19 kg/m2;
You likely can't join 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: people with chronic atrial...
- 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
See the full eligibility 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...
- Evidence of not pregnancy status as documented by a negative beta-human chorionic gonadotropin (ß-hCG) test
- 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: people with chronic atrial arrhythmia, ie, atrial fibrillation or paroxysmal supraventricular...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Roma, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.