Clinical trial · Interventional
Fasting-mimicking Diet in Patients Undergoing Active Cancer Treatment
Phase II Clinical Study of a Fasting-mimicking Diet in Patients Undergoing Oncologic Treatment
NCT03595540CI-TRIAL-00061591completedN/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 is a pilot, single arm prospective trial assessing feasibility, safety and effects on patient nutritional status of a 5-day fasting-mimicking diet (FMD) in patients with different cancer types and concomitant anticancer treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prolon | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prolon - FMD
- description
- Patients undergoing active cancer treatment are assigned monthly cycles of the fasting-mimicking diet Prolon
- interventionNames
- Other: Prolon
Primary outcomes (2)
- measure
- percentage of prescribed diet consumed and intake of any extra food
- timeFrame
- 6 months
- description
- Feasibility will be monitored through the compilation of a food diary and is defined as the strict adherence to the diet prescribed in all its days with the possibility to admit the consumption of only 50% of the planned diet and / or a maximum consumption of 4- 5 Kcal / kg of food not expected in only one of the days -2, -1, +1 of each cycle.
- measure
- Quantification of FMD-emergent adverse events
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Age \> 18 years * Patients with solid or hematologic tumors undergoing active treatment, including patients who are preparing to start a new treatment with chemotherapeutic regimens, hormone therapies, other molecularly targeted therapies (including kinase inhibitors), biologics (including trastuzumab) , pertuzumab, cetuximab and bevacizumab) or inhibitors of immune checkpoints (eg Opdivo, Keytruda), ie patients in whom treatment is already underway; * ECOG performance status 0-1 * Adequate organ function * BMI \>21 kg/m2 (with possibility to also enroll patients with 19\<BMI\<21 based on the judgement of the treating physician) * Low nutritional risk according to nutritional risk screening (NRS) Exclusion criteria: * Diabetes mellitus; * Previous therapy with IGF-1 inhibitors; * Food allergies to the components of the FMD; * BMI \<19 kg/m2; * bio-impedance phase angle \<5.0°; * medium/high nutritional risk according to NRS; * Any metabolic disorder that can affect gluconeogenesis or ability to adapt to fasting periods; * Patients who live alone or are not adequately supported by the family context; * Treatment in progress with other experimental therapies.
References
Publications (1)
- DERIVEDValdemarin F, Caffa I, Persia A, Cremonini AL, Ferrando L, Tagliafico L, Tagliafico A, Guijarro A, Carbone F, Ministrini S, Bertolotto M, Becherini P, Bonfiglio T, Giannotti C, Khalifa A, Ghanem M, Cea M, Sucameli M, Murialdo R, Barbero V, Gradaschi R, Bruzzone F, Borgarelli C, Lambertini M, Vernieri C, Zoppoli G, Longo VD, Montecucco F, Sukkar SG, Nencioni A. Safety and Feasibility of Fasting-Mimicking Diet and Effects on Nutritional Status and Circulating Metabolic and Inflammatory Factors in Cancer Patients Undergoing Active Treatment. Cancers (Basel). 2021 Aug 9;13(16):4013. doi: 10.3390/cancers13164013. PMID 34439167