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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT03340935
Eligibility Criteria:
Inclusion criteria:
* Cytologically or Histologically confirmed diagnosis of malignant neoplasm
* Capability of swallowing plant-based foods foreseen by the FMD
* Body mass index (BMI) ≥ 20 kg/m2
* Adequate bone marrow function, including:
1. Hemoglobin \> 9 g/dl
2. Piatelets \> 75,000/µl
3. Absolute neutrophil count (ANC) \> 1,500/µl
* Creatinine \< 1.5 mg/dl or calculated creatinine clearance ≥50 mL/min
* Uric acid \< 6 mg/dl
* Fasting glucose \> 65 mg/dl
* Total bilirubin \< 2 mg/dl or \< ULN, except for patients with Gilbert syndrome
* Written informed consent according to the local Ethics Committee requirements
* Willing and ability to accomplish blood and urinary examinations according to the protocol
* Ability to maintain a daily contact (by phone or email) with the study staff for the communication of crucial clinical information, including daily body weight, blood pressure, health status and adverse events during each of the 5 days on diet
Exclusion criteria:
* Small cell neuroendocrine carcinoma
* Unintentional weight loss ≥ 5% in the last 3-6 months
* Known HIV infection
* Pregnancy or lactation
* History of alcohol abuse
* Diagnosis of diabetes mellitus type I or type II that requires medical treatment
* Fasting glucose \> 200 mg/dl
* Clinically meaningful cardiovascular, renal or pulmonary diseases
* Current treatment with antipsychotics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03340935
Study Brief:
Protocol Section:
NCT03340935