Combining curcumin (C3-complex, Sabinsa) with standard care FOLFOX chemotherapy in patients with inoperable colorectal cancer (CUFOX): study protocol for a randomised control trial

Table 1 Definitions of diarrhoea and subsequent management according to the timing of symptoms in relation to administration of study drugs

	Diarrhoea grade
Definition/timing	1	2	3	4
Definition	Increase <4 stools/day over baseline; mild increase in ostomy output	Increase 4–6 stools/day over baseline; moderate increase in ostomy output	Increase ≥7 stools/day; incontinence; hospitalization indicated; severe increase in ostomy output limiting self-care	Life-threatening consequences; urgent intervention indicated
Pre-chemotherapy	Observe but continue to chemotherapy	Stop, stagger or reduce curcumin, continue chemotherapy when AE grade <2	Stop curcumin, continue with chemotherapy when AE grade <2	Stop curcumin, continue with chemotherapy when AE grade <2
During chemotherapy	Observe but continue chemotherapy	Reduce or stagger curcumin	Stop curcumin, continue or reduce chemotherapy as per protocol	Stop curcumin, continue reduced chemotherapy as per protocol
48 hours after one curcumin dose reduction	Observe but continue chemotherapy	Stop curcumin, continue or reduce chemotherapy as per protocol	Stop curcumin, continue or reduce chemotherapy as per protocol	Stop curcumin, continue or reduce chemotherapy as per protocol

Symptoms were defined according to the Common Terminology Criteria for Adverse Events (Version 4). AE, adverse event.

ISSN: 1745-6215