Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03595540 |
Other study ID # |
308CER2017 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 22, 2017 |
Est. completion date |
April 15, 2021 |
Study information
Verified date |
October 2022 |
Source |
University of Genova |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
It is proposed to conduct a single-arm phase II clinical study of a FMD (Prolon, by L-Nutra)
in 60 patients with solid or hematologic tumors who undergo treatment with chemotherapeutic
regimens, hormone therapies, other molecularly targeted therapies (including kinase
inhibitors), biological drugs (including trastuzumab, pertuzumab, cetuximab and bevacizumab)
or inhibitors of immune checkpoints (e.g. Opdivo, Keytruda).
Prolon is a FMD lasting five days. It consist of vegetable soups, broths, bars, olives,
crackers, herbal teas, supplements of vitamins and minerals. Day 1 of the FMD supplies ~4600
kJ (11% protein, 46% fat, and 43% carbohydrate), whereas days 2-to-5 provide ~3000 kJ (9%
protein, 44% fat, and 47% carbohydrate) per day.
Primary endpoints of the study are the feasibility and safety of monthly cycles of the FMD in
patients with solid or hematologic tumors who undergo active treatment. Feasibility is
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 of admitting the consumption of only
50% of the planned diet and / or a maximum consumption of 4-5 Kcal / kg body weight of food
not provided in only one of the five days of each cycle. Furthermore, the dosage of IGF-1 and
of urinary ketone bodies allow to identify further cases of non-adherence to the diet.
FMD-emergent side effects are monitored according to the NCI-CTCAE version 5.0.
Secondary endpoints include:
- patient nutritional status as monitored by weight, handgrip strength, bio-impedance and
serum markers (ferritin, transferrin, colinesterase).
- Quality of life (QLQ-C30)
- Clinical responses measured by CT, MRI or by blood chemistry tests, dosing of tumor
markers and / or molecular biology tests in the case of prostate tumors or hematologic
tumors (e.g. PSA in patients affected by prostate cancer, BCR / Abl mRNA in the case of
patients undergoing treatment with kinase inhibitors for CML; CM in the case of patients
undergoing treatment for multiple myeloma).
- Long-term efficacy (progression-free survival, overall survival).
- Effect of FMD on HOMA index, PCR, circulating levels of IGF-1 and urinary levels of
ketone bodies.
- Effect of FMD on lymphocyte subsets, NK cells and antigen-presenting cells with a role
documented in antitumor immunity.
It is foreseen that 60 patients will be enrolled.