Clinical Evidence

Curcumin inhibits cancer stem cell phenotypes in ex vivo models of colorectal liver metastases, and is clinically safe and tolerable in combination with FOLFOX chemotherapy
Cancer Lett. 2015; 364(2):135-41
Colon cancer remains to be the fourth most common cancer globally. While chemotherapy is commonly advised in subjects diagnosed with colon cancer, a high rate of chemo-resistance is observed in patients with colon cancer. In case of colorectal cancer the most recognized chemotherapy used is FOLFOX regimen, which consists of Oxaliplatin, 5-Fluorouracil and Folinic acid. The FOLFOX regimen has been relatively well tolerated in colon cancer patients, however, its dose limiting side effects have been common and in some cases cause life threatening diarrhea due to mucositis. Further, majority of patients over the period of treatment develop Oxaliplatin-induced neuropathy leading to cessation or dose reduction.

Curcumin’s anticancer activity has been well established in various preclinical and clinical studies. Further studies on the combination of Curcumin and chemotherapy have shown synergistic effect on cancer cell treatment. Clinical evidences show reduction in the tumor volume and metastatic features when combined with chemotherapy.

To assess the safety, tolerability and feasibility of administering oral Curcumin during standard FOLFOX chemotherapy for palliation of colorectal liver metastases.

Study Design:

In this phase I dose-escalation study, 12 patients histologically diagnosed with metastatic colorectal cancer and suitable for FOLFOX-based chemotherapy were given 500 mg (1 capsule) of oral Curcumin C3 Complex® daily, 7 days prior to the scheduled chemotherapy. Since no Curcumin-induced toxicities (CIT) were observed, the daily oral Curcumin was continued even after commencement of chemotherapy. The FOLFOX-based chemotherapy consisted of 2-weekly cycles of chemotherapy up to 12 cycles. Patients who completed two cycles of chemotherapy without reports of any Curcumin-induced toxicity were enrolled to the next improved dose of 1 g (2 capsules), daily followed by 2 g (4 capsules).

The parameters evaluated during the trial (i.e. at baseline and at the end of the study) included fasting glucose level and lipid profile (total cholesterol, LDL-C, HDL-C and Triglycerides) along with liver and kidney function tests.

  • It was observed that 50% of patients completed 12 cycles of chemotherapy with Curcumin and the average compliance rate across all participants was 93.8%
  • Target lesions were reduced by 30% in 58.3% of the patients treated with Curcumin. The highest response observed was a 75.8% reduction in lesions
  • It was also recorded that majority of the patients (91.7%) showed no adverse effects

Finally, researchers of the study concluded that this was the first-of-its-kind study to demonstrate the safety, efficacy and tolerability of Curcumin when combined with FOLFOX-based chemotherapy in limited number of patients. 

These positive outcomes encouraged in planning a randomised phase II study to compare FOLFOX vs. FOLFOX-Curcumin C3 Complex® combination efficacy in colon cancer patients.