Please select the outcome measures that correspond to the clinical trial below.
Title: Calorie-restricted, Ketogenic Diet and Transient Fasting vs. Standard Nutrition During Reirradiation for Patients With Recurrent Glioblastoma: the ERGO2 Study
Brief Summary: Increased glucose metabolism is characteristic for solid tumors. Thereby, glucose is important for the generation of ATP, supply of anabolic substrates and defense against reactive oxygen species in tumor cells. In preclinical models, restricting glucose availability using a ketogenic diet, calorie-restriction or transient fasting inhibits tumor growth.

Therefore, the purpose of the study is to evaluate whether a calorie-restricted, ketogenic diet and transient fasting can enhance the efficacy of reirradiation in patients with recurrent glioblastoma.


Options:
A: Change From Baseline in Participant Glucose When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Insulin When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Adiponectin When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Hemoglobin When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Hematocrit When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Platelet Count When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Bicarbonate When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Sodium When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Chloride When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Calcium When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Potassium When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Creatinine When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Triglycerides When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Weight When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Waist Circumference When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed (Baseline and 3 days); Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed (Baseline and 3 days)
B: Progression-free-survival (6 months)
C: Fat loss and lean mass retention (14 weeks); Weight loss (14 weeks); Absolute changes in body composition (14 weeks)
D: Changes in gene expression in subcutaneous adipose tissue measured by whole genome sequencing (Assessments at baseline (week 0), and after the intervention phase (week 13))

Answer: B