The Assessment Of The Complementary Chemotherapeutic Potential Of Nigella Sativa In Patients With Colorectal Cancer: A Randomized Clinical Trial
Background: Colorectal cancer (CRC) is among the leading cause of cancer-related morbidity worldwide. Surgery and chemotherapy are the first-line therapy for CRC patients; however, the efficacy and side effects are two major concerns. Nigella sativa (NS) has been found to exhibit anti-cancer effects in numerous in vitro studies. The present study aimed to evaluate the potential therapeutic effect of NS on CRC patients.
Methods: In this randomized trial, a total of 39 patients with Stage IIb and III CRC who underwent colon surgery were randomly assigned to receive routine chemotherapy drugs in combination with 900 mg/day of NS (Group 1, n=18) or only chemotherapy drugs (Group 2, n=21). CRC blood biomarkers including CEA and CA19-9 were measured in both groups before, in the middle, and at the end of treatment in addition to obtaining demographic characteristics.
Results: We observed that NS combined with chemotherapy reduced the CA19-9 serum level in the intervention group when compared with the baseline level before treatment. However, there was no significant difference between CA19-9 serum levels in the intervention group compared with the control group at all time points. Moreover, CEA did not show any reduction in the intervention group compared with the control group.
Conclusion: Except for the NS effect on CA19-9 level in intervention group after therapy compared to baseline, NS is not effective on CRC biomarkers with this concentration and follow-up period. Therefore, longer treatment durations and monitoring with higher doses are probably required.