Short-term Fasting Compared to Free Diet on Ovarian Cancer Patients

NCT07039331 | Recruiting

• 1 other identifier: DIETA - ID 3819
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• The effects of short-term fasting and free diet on ovarian cancer

  The study primary endpoint is the reduction in mean Insulin (µU/ml) levels among different groups.

  At the end of cycle 3 (each cycle is 21 days)

Study Arms (2)

Short-Term Fasting

EXPERIMENTAL

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).

Dietary Supplement: Short Term Fasting

Free Diet

ACTIVE COMPARATOR

Patients of this group will be invited to follow with their ordinary diet without any change.

Other: Free Diet

Interventions

Short Term Fasting DIETARY_SUPPLEMENT

Short Term Fasting during the first three cycles of NACT (36h before and 24h after the end of each cycle of CT).

Short-Term Fasting

Free Diet OTHER

Ordinary diet during the first three cycles of NACT without any change.

Free Diet

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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: 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
• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

DH Tumori Femminili

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Claudia Marchetti

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

claudia marchetti

CONTACT

0630158556; claudia.marchetti@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, open-label exploratory randomized clinical trial evaluating the effect of STF on OC patients, receiving NACT with carboplatin and paclitaxel. Potential participants will be screened for eligibility during an appointment at the study center, and eligible candidates will be scheduled for an enrolment appointment. The study physician will perform the candidates' physical examinations. Subjects height and body weight will be measured following a standardized protocol. Body Mass Index (BMI) will be calculated as \[weight (kg)\] / \[height (m)\]2. Patient's adverse effects (AE) to the different diets will be recorded on a diary during the entire protocol period. Subjects who meet all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1:1 ratio to one of three arms, as follows: * Arm A: Short-Term Fasting * Arm B: Free Diet (control arm)

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: June 26, 2025
• Study Start: December 7, 2021
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

IT (1)