Curcumin Combined with FOLFOX Chemotherapy Is Safe and Tolerable in Patients with Metastatic Colorectal Cancer in a Randomized Phase IIa Trial.

 

J Nutr.2019; 159 (7): 1133-1139. DOI: 10.1093/jn/nxz029

FOLFOX is a chemotherapy regimen for treatment of colorectal cancer, made up of the drugs FOL– Folinic acid (leucovorin), F – Fluorouracil (5-FU), OX – Oxaliplatin. Though, the treatment is effective tolerability is an issue during the drug treatment regime. Adjuvants which can improve the tolerability and even efficacy are under investigation. Curcumin has been shown to be promising adjuvant in preclinical observations and has been under validation in human subjects suffering from cancer.

 

Objective:

To assess the safety, efficacy, quality of life, neurotoxicity, curcuminoids, and C-X-C-motif chemokine ligand 1 (CXCL1) in patients receiving folinic acid/5-fluorouracil/oxaliplatin chemotherapy (FOLFOX) compared with FOLFOX + 2 g oral curcumin/d (CUFOX).

 

Methods:

The study was Phase IIa open-labeled randomized controlled trial involving twenty-eight patients with metastatic colorectal cancer. The subjects were randomly grouped to receive either FOLFOX or CUFOX. Safety was assessed by Common Toxicity Criteria-Adverse Event reporting, and efficacy via progression-free survival (PFS) and overall survival (OS). Quality of life and neurotoxicity were assessed using questionnaires (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and Functional Assessment of Cancer Treatment-Gynecologic Oncology Group-Neurotoxicity). Plasma curcuminoids were determined with liquid chromatography (LC) electrospray ionization tandem mass spectrometry and CXCL1 by ELISA.

 

Results:

  • The addition of daily oral curcumin to FOLFOX chemotherapy was safe and tolerable.
  • Similar adverse event profiles were observed for both groups.
  • There was no significant difference between arms for quality of life or neurotoxicity.
  • Curcumin glucuronide was detectable at concentrations >1.00 pmol/mL in 15 of 18 patients receiving CUFOX. Curcumin did not significantly alter CXCL1 over time.

 

Conclusion:

Curcumin is a safe and tolerable adjunct to FOLFOX chemotherapy in patients with metastatic colorectal cancer.

 

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