Table 3 Overview of study assessments of the VIVROVAIRE TR Study
Study Period | |||
|---|---|---|---|
Enrollment | Step 1 | Step 2 | |
Eligibility Screen | • | ||
Informed Consent | • | ||
Disease medical history | • | ||
Chronic fatigue, quality of life and late effects of chemotherapy | • | ||
✓ Fatigue (MFI-20a) | • | ||
✓ Quality of life (FACT-Gb/FACT-Oc) | • | ||
✓ Neurotoxicity (FACT/GOG-NTXd) | • | ||
✓ Cognition (FACT-Coge) | • | ||
✓ Day-to-day life (Living condition questionnaire) | • | ||
✓ Anxiety /Depression (HADSf) | • | ||
✓ Insomnia (ISIg) | • | ||
✓ Physical activity (IPAQh) | • | ||
✓ EQ-5Di (For patients only) | • | ||
Specialized medical examination | • | ||
Cardiovascular: | |||
a) Cardio-vascular medical examination with non-invasive tests to explore heart disease (by a cardiologist) | • | ||
- Electrocardiogram | • | ||
- Echocardiography | • | ||
-Coronary endothelium-dependent vasoreactivity testing (optional exam) | • | ||
b) Non-invasive vascular tests to explore atherosclerosis: | • | ||
- Systolic index of lower and upper limbs, | • | ||
-Ultrasound images to measure carotid intima media thickness | • | ||
- Capillaroscopy to assess Raynaud’s syndrome (optional exam) | • | ||
c) Specific cardiac biological tests: | • | ||
High-sensitive cardiac troponin, BNP, Von Willebrand factor (VWf), tissular Plasminogen Activator (t-PA). | • | ||
Respiratory & Hearing: | • | ||
- Respiratory Function Tests (RFT) | • | ||
- Audiogram | • | ||
Blood sampling: exploring metabolic and hormonal disorders | • | ||
- Hormonal assessment: sex hormone binding globulin (SHBG), Luteinizing hormone (LH), Follicle-stimulating hormone (FSH), Estradiol, Anti-Müllerian hormone (AMH), thyroid stimulating hormone (TSH). | • | ||
-Carbohydrate-lipid balance: fasting blood glucose and insulin, lipid fractions, triglycerides; | • | ||
- Osteocalcin blood Tests: calcium, phosphorus, vitamin D | • | ||
- Renal assessment: ionograms, creatinine level | • | ||
-Hepatic assessment: transaminases (TGO, TGP), Aspartate Aminotransferase (ASAT), Alanine Aminotransferase (ALAT), Alkaline Phosphatase (PAL), Gamma-glutamyl transferase (GGT), Lactate dehydrogenase (LDH | • | ||
- C-Reactive Protein Test ultrasensitive | • | ||