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Table 1 Study schedule

From: Ketogenic diets as an adjuvant therapy in glioblastoma (the KEATING trial): study protocol for a randomised pilot study

 

Study period

 

Enrolment/diet allocation

Post allocation (on diet)

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Timeline

 

1 week post-histology

1 week after clinic 1

1 weeks after clinic 2

3 weeks after clinic 2

6 weeks after clinic 2

9 weeks after clinic 2

12 weeks after clinic 2

6 months after clinic 2

9 months after clinic 2

12 months after clinic 2

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Post-histology

± 5 days

± 5 days

before radiotherapy

± 3 days

± 3 days

± 5 days

± 3 days

± 5 days

± 10 days

± 10 days

± 10 days

Clinic visit

Telephone discussion

Clinic appointment 1

Consent, register, baseline assessment, randomisation

Clinic appointment 2

Commence diet

Telephone review 1

Telephone review 2

Clinic appointment 3

Diet review

Telephone review 3

Clinic appointment 4

Diet review

Clinic appointment 5

Diet review

Clinic appointment 6

Diet review

Clinic appointment 7

Diet review

End of trial

Information sheet

X

          

Informed consent

 

X

         

Eligibility screen

 

X

         

Randomisation

 

X

         

Medical history review

 

X

         

Medications review

 

X

         

Anthropometry

 

X

   

X

 

X

X

X

X

Biochemistry

 

X

     

X

X

X

X

Food diary

 

X

   

X

 

X

X

X

X

Ketone diary

     

X

 

X

X

X

X

Quality of life (QoL) questionnaire EORCT QLQ C30

 

X

   

X

 

X

X

X

X

QoL questionnaire QLQ BN20

 

X

   

X

 

X

X

X

X

Food Acceptability Questionnaire

 

X

   

X

 

X

X

X

X

Dietary review

 

X

X

X

X

X

X

X

X

X

X

Ketone review

   

X

X

X

X

X

X

X

X

  1. X = procedure carried out