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Table 1 Visit overview

From: Short-term fasting accompanying chemotherapy as a supportive therapy in gynecological cancer: protocol for a multicenter randomized controlled clinical trial

  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    
  1. aInterventions take place only during chemotherapy
  2. bOnly in a subpopulation of n = 20