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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