| Study period | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
 | Enrolment/diet allocation | Post allocation (on diet) | Close out | ||||||||
Timeline | Â | 1Â week post-histology | 1Â week after clinic 1 | 1Â weeks after clinic 2 | 3Â weeks after clinic 2 | 6Â weeks after clinic 2 | 9Â weeks after clinic 2 | 12Â weeks after clinic 2 | 6Â months after clinic 2 | 9Â months after clinic 2 | 12Â months after clinic 2 |
Visit window | 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 | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Informed consent | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Eligibility screen | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Randomisation | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history review | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medications review | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Anthropometry | Â | X | Â | Â | Â | X | Â | X | X | X | X |
Biochemistry | Â | X | Â | Â | Â | Â | Â | X | X | X | X |
Food diary | Â | X | Â | Â | Â | X | Â | X | X | X | X |
Ketone diary | Â | Â | Â | Â | Â | X | Â | X | X | X | X |
Quality of life (QoL) questionnaire EORCT QLQ C30 | Â | X | Â | Â | Â | X | Â | X | X | X | X |
QoL questionnaire QLQ BN20 | Â | X | Â | Â | Â | X | Â | X | X | X | X |
Food Acceptability Questionnaire | Â | X | Â | Â | Â | X | Â | X | X | X | X |
Dietary review | Â | X | X | X | X | X | X | X | X | X | X |
Ketone review | Â | Â | Â | X | X | X | X | X | X | X | X |