Oral curcumin-containing supplement will be given to colorectal cancer patients with unresectable metastases who will be starting Avastin/FOLFIRI chemotherapy for up to completion of (or withdrawal from) chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Avastin: 5mg/kg iv on day1, every 14 days. Irinotecan: 180 mg /m2 iv on day1, every 14 days. Leucovorin: 200 mg/m2 iv on day1,2 every 14 days. 5-fluorouracil bolus: 400 mg/m2 iv on day1,2 every 14 days. 5-fluorouracil infusion: 1200 mg/m2 iv on day1,2 every 14 days.
Dietary supplement of nanostructured lipid curcumin particle 100mg po bid daily
Progression-free survival
The primary end point of this study is to evaluate progression-free survival in colorectal cancer patients with unresectable metastasis after treatment with first line Avastin/FOLFIRI in combination with a dietary supplement of nanostructured lipid curcumin particle (Aju Pharm, Korea), which improved biotransformation and bioavailability profiles of curcumin.
Time frame: 2 years
Overall survival rate
Overall survival will be measured in months. Overall survival will be measured in months. Overall survival will be measured in months. Overall survival will be measured in months.
Time frame: 3 years
Overall response rate
According to RECIST criteria v1.1
Time frame: 2 years
Safety (assessed by toxicity grades defined by NCI-CTCAE (version 4.0)
Safety as assessed by toxicity grades defined by NCI-CTCAE (version 4.0)
Time frame: 2 years
Quality of life (QoL)
QoL measured by the FACT-G (version 4, Korean version)
Time frame: 2 years
Fatigue (FACIT-Fatigue scale (version 4, Korean version)
Fatigue measured by the FACIT-Fatigue scale (version 4, Korean version)
Time frame: 2 years
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