Health Condition 1: C188- Malignant neoplasm of overlappingsites of colon
Conditions
Interventions
Intervention1: Tab. Curcuma longa 550 mg: Tab. Curcuma longa 550 mg, 3 times a day daily from the day of initiation of chemotherapy to 8 cycles along with the CAPOX regimen
Control Intervention1: Tab.
Sponsors
JIPMER Intramural fund
Eligibility
Inclusion criteria
Inclusion criteria: Patient of age >18 years of age, diagnosed de novo or recurrent metastatic colorectal cancer and planned to be started with first-line CAPOX regimen, ECOG performance status <2
Exclusion criteria
Exclusion criteria: Patients with human immunodeficiency virus, hepatitis B, or Hepatitis C infection Pregnant or lactating women Impaired renal function defined as creatinine >1.5 mg/dl Upper normal limit (UNL) Impaired hematological function defined by ANC Impaired liver function is defined as AST & ALT ââ?°Â¥ 2.5 Ã?â?? UNL, total serum bilirubin ââ?°Â¥1.5 UNL, Alkaline phosphatase ââ?°Â¥ 2.5 Ã?â?? UNL Significant cardiovascular disease defined as LVEF < 50%/ myocardial infarction/stroke within the last 6 months, NYHA Class ââ?°Â¥ 3 heart failure, history of QT prolongation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate (ORR) at the end of 8 cycles of treatment in metastatic colorectal patientsTimepoint: 0 cycle, 8 cycles of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life by EORTC QLQ-C30 questionnaire (V3.0)Timepoint: end of 1st, 2nd, 3rd , 4th, 5th, 6th, 7th and 8th cycles of chemotherapy;Adverse effectsTimepoint: end of 1st, 2nd, 3rd , 4th, 5th, 6th, 7th and 8th cycles of chemotherapy;Median progression free survivalTimepoint: Till the end of study to available follow up;objective response rate (ORR) at the end of 4 cycles of treatment in metastatic colorectal patientsTimepoint: 0 cycle, at end of 4th cycle of chemotherapy | — |
Countries
India
Contacts
Public ContactDr Ilanthamizhan J
JIPMER, Puducherry
Outcome results
None listed