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Table 1 Trial process chart

From: Effect of YH0618 soup on chemotherapy-induced toxicity in patients with cancer who have completed chemotherapy: study protocol for a randomized controlled trial

 

Before baseline screening

Baseline

Visit 1

Treatment phase

Visit 2

Treatment phase

Visit 3

Follow-up phase

Process items

 

0 day

3 weeks

6 weeks

12 weeks

Patients

     

 Inclusion and exclusion criteria

×

    

 Informed consent

 

×

   

 Demographics

 

×

   

 Medical history

×

×

   

 Randomization and allocation concealment

 

×

   

Primary outcomes

     

 Grading of dermatologic toxicity

 

×

×

×

×

 Objective skin, nail, and tongue color (L*a*b)

 

×

×

×

×

Secondary outcomes

     

 Fatigue measurement score

 

×

×

×

×

 Routine blood test (WBC, HGB, PLT)

 

×

×

×

×

 Liver function (ALT, AST, total protein, Alba)

 

×

×

×

×

 Renal function (Cr and BUN)

 

×

×

×

×

Adverse events

  

×

×

×

Patients’ diary records

 

Every day during the study