Does a ketogenic diet as an adjuvant therapy for drug treatment enhance chemotherapy sensitivity and reduce target lesions in patients with locally recurrent or metastatic Her-2-negative breast cancer? Study protocol for a randomized controlled trial

Table 3 Criteria for irinotecan dose adjustment due to liver toxicity

AST/ALT	Alkaline phosphatase level	Dose adjustment
< 1.5 × ULN	< 5 × ULN	No dose adjustment
1.5 × ULN to < 2.5 × ULN	< 2.5 × ULN	No dose adjustment
2.5 × ULN to < 5 × ULN	< 2.5 × ULN	The irinotecan dose will be reduced by 20%.
> 1.5 × ULN to < 5 × ULN	> 2.5 × ULN to < 5 × ULN	The irinotecan dose will be reduced by 20%.
> 5 × ULN and/or > 5 × ULN (except for bone metastases without any liver damage)		If recovery is not achieved within 3 weeks, the patient will be withdrawn from the trial

ALT alanine aminotransferase, AST aspartate aminotransferase, ULN upper limit of normal

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