Clinical trial · Interventional
Short-term Fasting Compared to Free Diet on Ovarian Cancer Patients
The Effects of Short-term Fasting Compared to Free Diet on Ovarian Cancer Patients: A 2-Arms Pilot Randomized Study
NCT07039331CI-TRIAL-00091603DIETArecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Free Diet | Other | — | UNRESOLVED |
| Short Term Fasting | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Short-Term Fasting
- description
- Each eligible participant will undergo Short Term Fasting of a total of 60 h during the first three cycles of NACT (36h before and 24h after the end of each cycle of CT).
- interventionNames
- Dietary Supplement: Short Term Fasting
- type
- ACTIVE_COMPARATOR
- label
- Free Diet
- description
- Patients of this group will be invited to follow with their ordinary diet without any change.
- interventionNames
- Other: Free Diet
Primary outcomes (1)
- measure
- The effects of short-term fasting and free diet on ovarian cancer
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.