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 2 Schedule of tests and procedures

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

¹Can be obtained at any point prior to start of trial. ²Patients on folinic acid/5-fluorouracil/oxaliplatin (FOLFOX) chemotherapy will routinely have these blood tests done prior to each cycle. ³If no radiological assessment of disease (computed tomography (CT)/magnetic resonance imaging (MRI) of chest, abdomen and pelvis) has been done within 28 days of screening, a trial baseline scan (CT/MRI of chest, abdomen and pelvis) must be completed within 28 days of the patient’s first cycle of chemotherapy. CT scans should be repeated every six cycles (12 weeks) during FOLFOX and then 3-monthly to 24 months and 6-monthly to 48 months. ⁴Research samples after final cycle should be as close to 14 days as possible, but more than 7 and can be arranged to coincide with the next clinic appointment. ⁵FOLFOX will be up to 12 cycles (approximately 24 weeks). Central line is placed prior to chemotherapy by trained staff. ⁶Direct patient involvement in the trial will cease after curcumin has been completed. Patient episodes following this will be confined to follow-up CT scans. Patients will remain in the standard care pathway. CEA, chorioembryonic antigen; ECOG, Eastern Cooperative Oncology Group; EORTC-QLQ30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire form 30.

ISSN: 1745-6215