Clinical trial · Interventional
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies
Use of a Fasting Mimicking Diet in Patients Undergoing Chemotherapy for Gynecologic Malignancies
NCT06376604CI-TRIAL-00076298unknownN/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)
This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Calorie Deficiency | — | UNRESOLVED | — |
| Cancer, Ovarian | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy Effect | — | UNRESOLVED | — |
| Fasting, Intermittent | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Fasting Mimicking Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FMD
- description
- In addition to the standard care, subject will consume a 5-day fasting mimicking diet.
- interventionNames
- Other: Fasting Mimicking Diet
- Drug: Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Subjects will receive the standard care and no dietary changes.
- interventionNames
- Drug: Chemotherapy
Primary outcomes (2)
- measure
- Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Women * Age 35-70 years old (both inclusive) * Biopsy proven gynecologic malignancy * Scheduled to or currently undergoing chemotherapy, with a minimum of 6 cycles remaining * BMI greater than or equal to 18.5 * Adequate renal function (serum creatinine less than 1.5 times the upper limit of normal) * Willing to adhere to a 5-day fasting mimicking diet Exclusion Criteria: * Pregnant or nursing mothers * Prisoners * Patients with diabetes or history of hypoglycemia * Taking daily medications that cannot be safely taken without food * History of significant or unstable cardiac disease such as congestive heart failure or history of myocardial infarction, stroke or pulmonary embolism within the last 3 months, renal failure, history of - eating disorder, dementia, psychosis, impaired physical mobility. * Significant medical comorbidity that would be dangerous with a fasting mimicking diet. * Any known or suspected food allergies that overlap with the FMD/Transitional diet by L-Nutra meal kit ingredients.
References
Publications (8)
- BACKGROUNDCaffa I, Spagnolo V, Vernieri C, Valdemarin F, Becherini P, Wei M, Brandhorst S, Zucal C, Driehuis E, Ferrando L, Piacente F, Tagliafico A, Cilli M, Mastracci L, Vellone VG, Piazza S, Cremonini AL, Gradaschi R, Mantero C, Passalacqua M, Ballestrero A, Zoppoli G, Cea M, Arrighi A, Odetti P, Monacelli F, Salvadori G, Cortellino S, Clevers H, De Braud F, Sukkar SG, Provenzani A, Longo VD, Nencioni A. Fasting-mimicking diet and hormone therapy induce breast cancer regression. Nature. 2020 Jul;583(7817):620-624. doi: 10.1038/s41586-020-2502-7. Epub 2020 Jul 15. PMID 32669709
- BACKGROUNDde Groot S, Lugtenberg RT, Cohen D, Welters MJP, Ehsan I, Vreeswijk MPG, Smit VTHBM, de Graaf H, Heijns JB, Portielje JEA, van de Wouw AJ, Imholz ALT, Kessels LW, Vrijaldenhoven S, Baars A, Kranenbarg EM, Carpentier MD, Putter H, van der Hoeven JJM, Nortier JWR, Longo VD, Pijl H, Kroep JR; Dutch Breast Cancer Research Group (BOOG). Fasting mimicking diet as an adjunct to neoadjuvant chemotherapy for breast cancer in the multicentre randomized phase 2 DIRECT trial. Nat Commun. 2020 Jun 23;11(1):3083. doi: 10.1038/s41467-020-16138-3. PMID 32576828
- BACKGROUNDFinnell JS, Saul BC, Goldhamer AC, Myers TR. Is fasting safe? A chart review of adverse events during medically supervised, water-only fasting. BMC Complement Altern Med. 2018 Feb 20;18(1):67. doi: 10.1186/s12906-018-2136-6. PMID 29458369
- BACKGROUNDGoncalves MD, Cantley LC. A 'fast'er way to treat breast cancer. Nat Metab. 2020 Jul;2(7):559-560. doi: 10.1038/s42255-020-0225-6. No abstract available. PMID 32694797
- BACKGROUNDLee C, Raffaghello L, Brandhorst S, Safdie FM, Bianchi G, Martin-Montalvo A, Pistoia V, Wei M, Hwang S, Merlino A, Emionite L, de Cabo R, Longo VD. Fasting cycles retard growth of tumors and sensitize a range of cancer cell types to chemotherapy. Sci Transl Med. 2012 Mar 7;4(124):124ra27. doi: 10.1126/scitranslmed.3003293. Epub 2012 Feb 8. PMID 22323820
- BACKGROUNDRaffaghello L, Safdie F, Bianchi G, Dorff T, Fontana L, Longo VD. Fasting and differential chemotherapy protection in patients. Cell Cycle. 2010 Nov 15;9(22):4474-6. doi: 10.4161/cc.9.22.13954. Epub 2010 Nov 15.