Effects of modified fasting on cancer patients
Phase I / II Single Arm Study: Metabolic and Immunological Effects of a Modified Fasting Regimen in Cancer Patients
This study tests whether a short-term modified fasting diet can improve treatment outcomes and immune function in cancer patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Genova Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Genova) |
| Trial ID | NCT05748704 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the metabolic and immunological effects of a short-term modified fasting regimen in cancer patients undergoing various treatments. It involves 100 participants with solid tumors or hematological malignancies, assessing changes in circulating factors related to tumor growth and immune response. The regimen consists of a 5-day low-calorie and low-protein diet, with comprehensive medical and nutritional assessments conducted. The study aims to understand how fasting influences cancer treatment outcomes and immune function.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with solid or hematological tumors who are undergoing active treatment or are on a watchful waiting approach.
Not a fit: Patients over 65 years old or those with high nutritional risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of cancer treatments and improve patient outcomes.
How similar studies have performed: While the approach of modified fasting in cancer treatment is emerging, similar studies have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Genova
- San Martino Hospital — Genova, Italy (Recruiting)
Study contacts
- Principal investigator: Alessio Nencioni, MD — Universita degli Studi di Genova
- Study coordinator: Alessio Nencioni, MD
- Email: alessio.nencioni@unige.it
- Phone: +39 010 353
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.