Observation | Screening pre-curcumin | Week 1/curcumin loading | Week 3/before 2ndcycle | Week 5/before 3rdcycle | Week 24/after cycle 12 or withdrawal |
---|---|---|---|---|---|
Informed consent1 | X | Â | Â | Â | Â |
EORTC QLQ-C30 | X | Â | Â | Â | X |
Curcumin questionnaire | X | Â | Â | Â | X |
Medical history | X | Â | Â | Â | Â |
Physical examination | X | Â | Â | Â | Â |
Weight, temperature, blood pressure, pulse | X | Â | X | X | X |
ECOG performance status (Appendix 2) | X | Â | Â | Â | X |
12-lead electrocardiogram | X | Â | Â | Â | Â |
Haematology, liver function, renal function2 | X | Performed as routine prior to each cycle of FOLFOX | |||
Urine sample (pregnancy test for female patients) | X | Â | Â | Â | Â |
Tumour assessment3 | X | 3-monthly CT scan to 24Â months. | |||
6-monthly CT 24 to 48Â months when appropriate | |||||
Serum CEA2 | X | 3-monthly CEA until CT scans end | |||
Symptom diary | X | Daily for first 4Â weeks | Â | ||
Neurotoxicity questionnaire | X | Questionnaire every 2Â cycles, after cycle 12 or withdrawal | |||
Blood samples for curcumin, platinum and biomarker analysis | X | X | X | X | X4 |
FOLFOX treatment5 | Â | Up to 12Â cycles, at 2Â week intervals | |||
Survival | Â | Continuously monitored once protocol therapy has ended6 |