Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT05748704
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05748704
Study Brief:
Protocol Section:
NCT05748704