Clinical trial · Interventional
Metabolic and Immunological Effects of a Modified Fasting Regimen in Cancer Patients
Phase I / II Single Arm Study: Metabolic and Immunological Effects of a Modified Fasting Regimen in Cancer Patients
NCT05748704CI-TRIAL-00064363unknownN/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 single-arm prospective pilot study assessing the metabolic and immunologic effects of a modified fasting regimen in cancer patients with different cancer types and concomitant anticancer treatment.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Short-term modified fasting | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Short-term modified fasting
- description
- The STMF regimen consists of a low-calorie diet lasting five days and aimed at providing between 800 and 1,000 kcal/day (tentatively 10% carbohydrates, 15% proteins, 75% lipids).
- interventionNames
- Other: Short-term modified fasting
Primary outcomes (6)
- measure
- Effects of the STMF on IGF1 and IGFBP1
- timeFrame
- month 1-12
- description
- IGF1 and IGFBP1 dosage (μg/l)
- measure
- Effects of the STMF on IGFBP3
- timeFrame
- month 1-12
- description
- IGFBP1 dosage (mg/l)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Age \> 18 years * Patients with solid or hematologic tumors undergoing active treatment (including chemotherapy regimens, hormone therapies, other molecularly targeted therapies - including kinase inhibitors, biologicals or inhibitors of immune checkpoints; patients in whom treatment is already ongoing are also eligible; patients with haematological malignancies who are managed by watchful waiting (e.g. low-risk B-CLL or follicular lymphoma) as well as patients with relapsing forms of non-melanoma skin cancer (basal or squamous cell carcinoma) are also eligible. * ECOG performance status 0-1 * Adequate organ function * BMI \>21 kg/m2 (with possibility to also enroll patients with 18.5\<BMI\<21 based on the judgement of the treating physician) * Low nutritional risk according to nutritional risk screening (NRS) Exclusion Criteria: * Age\> 65 years \[with the possibility to enroll from 65 to 75 years old patients if considered safe by the examining doctor * Diabetes mellitus; * BMI \<18.5 kg/m2; * Bio-impedance phase angle \<5.0°; * Medium/high nutritional risk according to NRS; * Any metabolic disorder capable of affecting gluconeogenesis or the ability to adapt to periods of fasting; * Ongoing treatment with other experimental therapies.
References
Publications (0)
Data not yet available
No reference posted for this study.