Ovarian CancerDIETANCT07039331
Short-term Fasting Compared to Free Diet on Ovarian Cancer Patients
A study testing Short Term Fasting and Free Diet in people with Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Short Term Fasting and Free Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 7 Dec 2021to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
DH Tumori Femminili
Roma
Claudia Marchetti, claudia.marchetti@policlinicogemelli.it
About this study
Official title: The Effects of Short-term Fasting Compared to Free Diet on Ovarian Cancer Patients: A 2-Arms Pilot Randomized Study
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.
Read the detailed description
The aim of this study is to investigate the effect of STF on OC patients, receiving NACT. The impact on metabolic and endocrine parameters will be investigated, including Insulin level, in order to correlate IGF-1 values and clinical response rate. In particular, the study aims at investigating the reduction in mean insulin levels among different groups (primary endpoint); the effects of the different dietary regimens on metabolic, endocrine, haematologic, inflammatory and tumoral marker response to NACT, the impact of STF on body weight and body composition, ORR, tolerability and toxicity grade experienced by each patient, PFS, QoL and OS will be investigated as secondary clinical outcomes. As translational endpoints, the study will assess the ability of different dietary regimens to modify the immune system; also, the influence of gut microbiota on the chemotherapeutic regimen and on the immune system status in correlation with dietary approach will be explored. Finally, the correlation of intestinal resection during IDS and thereafter the modulation of gut microbiota will be investigated
- Conditions
- Ovarian Cancer
- Being tested
- Short Term Fasting, Free Diet
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Term FastingDietary supplement
Short Term Fasting during the first three cycles of NACT (36h before and 24h after the end of each cycle of CT).
Free DietOther
Ordinary diet during the first three cycles of NACT without any change.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Free Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of cycle 3 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start7 Dec 2021
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARCHETTI CLAUDIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Claudia Marchetti, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039331
- Sponsor's protocol ID
- DIETA - ID 3819
- Acronym
- DIETA
- Status last verified
- Jun 2025
- First submitted
- 5 Mar 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Short-term Fasting Compared to Free Diet on Ovarian Cancer Patients: A 2-Arms Pilot Randomized Study
- ClinicalTrials.gov ID
- NCT07039331
- Acronym / sponsor ID
- DIETA / DIETA - ID 3819
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study is to investigate the effect of STF on OC patients, receiving NACT. The impact on metabolic and endocrine parameters will be investigated, including Insulin level, in order to correlate IGF-1 values and clinical response rate. In particular, the study aims at investigating the reduction in mean insulin levels among different groups (primary endpoint); the effects of the different dietary regimens on metabolic, endocrine, haematologic, inflammatory and tumoral marker response to NACT, the impact of STF on body weight and body composition, ORR, tolerability and toxicity grade experienced by each patient, PFS, QoL and OS will be investigated as secondary clinical outcomes. As translational endpoints, the study will assess the ability of different dietary regimens to modify the immune system; also, the influence of gut microbiota on the chemotherapeutic regimen and on the immune system status in correlation with dietary approach will be explored. Finally, the correlation of intestinal resection during IDS and thereafter the modulation of gut microbiota will be investigated
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Short-Term Fasting | Experimental | Dietary Supplement: Short Term FastingEach 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). |
| Free Diet | Active comparator | Other: Free DietPatients of this group will be invited to follow with their ordinary diet without any change. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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;
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Term FastingShort Term Fasting 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 DietOrdinary diet during the first three cycles of NACT without any change. | Other | Free Diet |
Primary outcome
The effects of short-term fasting and free diet on ovarian cancer
Time frame: At the end of cycle 3 (each cycle is 21 days)
The study primary endpoint is the reduction in mean Insulin (µU/ml) levels among different groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia Marchetti principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Term Fasting and Free Diet in people with Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact claudia marchetti (0630158556, claudia.marchetti@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of short-term fasting and free diet on ovarian cancer (time frame: At the end of cycle 3 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.