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

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

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