Study period | |||||||
---|---|---|---|---|---|---|---|
Screening (visit − 1) | Baseline (visit 0) | Visit | Follow-up | ||||
1 | 2 | 3 | 4 | 5 | |||
Week | − 1 | 0 | 16 ± 2 | 3 (− 1/+ 2) weeks after Chemotherapy | 48 ± 2 | 96 ± 2 | 144 ± 2 |
Enrolment | |||||||
Eligibility screen | X | ||||||
Informed consent | X | ||||||
Randomization | X | ||||||
Allocation | X | ||||||
Interventionsa | |||||||
Intermittent fasting | |||||||
Plant-based, sugar-restricted diet | |||||||
Nutritional counseling | X | ||||||
Assessments | |||||||
Demographic data | X | ||||||
Medical history | X | ||||||
Concomitant medication | X | X | X | X | X | X | |
Anthropometric measurements | X | X | X | X | X | X | |
Vital signs (blood pressure, heart rate) | X | X | X | X | X | X | |
Bioelectrical impedance analysis | X | X | X | X | X | X | |
Physical examination | X | X | X | X | X | X | |
AE/SAE query | X | X | X | X | X | ||
Blood panel Blood values for liver and renal function IGF-1, insulin, glucose, and ketone bodies in blood samples of subgroupb IGF-1, insulinb Ketone bodiesb | X | Timing varies according to individual therapy plan. | |||||
X | Timing varies according to individual therapy plan. | ||||||
X | X | ||||||
Prior to the first chemotherapy prior to each of the first four chemotherapies | |||||||
Long-term explorative measurements: e.g., polyneuropathy, cardiomyopathy Frequency of recurrence | X | X | X | ||||
X | X | X | |||||
CTCAE | X | X | X | X | X | ||
Questionnaires | |||||||
FACT-G | X | X | X | X | X | X | |
TOI (= PWB+FWB+AC) | X | X | X | X | X | X | |
Total AC (FACT-B/FACT-O) | X | X | X | X | X | X | |
FACIT-F | X | X | X | X | X | X | |
FACT-Tax,FACT/GOG-Ntx | X | X | X | X | X | X | |
CIPNAT | X | X | X | X | X | X | |
HADS | X | X | X | X | X | X | |
Side effects of chemotherapy | X | X | X | X | X | X | |
Qualitative interviews in focus groups | X | X |