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Title: Combining curcumin (C3-complex, Sabinsa) with standard care FOLFOX chemotherapy in patients with inoperable colorectal cancer (CUFOX): study protocol for a randomised control trial.
Authors: Irivng, Glen R.. B.
Iwuji, Chinenye O. O.
Morgan, Bruno
Berry, D. P.
Steward, William P.
Thomas, Anne
Howells, Lynne M.
First Published: 2015
Publisher: BioMed Central
Citation: Trials (2015) 16:110
Abstract: Background: The need for low toxicity adjuncts to standard care chemotherapy in inoperable colorectal cancer, with potential to improve outcomes and decrease the side-effect burden, is well recognised. Addition of the low toxicity diet-derived agent, curcumin (the active ingredient of turmeric), to standard oxaliplatin-based therapy has shown promise in numerous pre-clinical studies. Methods/Design: This study is the first to combine daily oral curcumin with standard care FOLFOX-based (5-fluorouracil, folinic acid and oxaliplatin) chemotherapy in colorectal cancer patients with inoperable liver metastases: the CUFOX trial. CUFOX comprises a Phase 1 dose-escalation study (3 + 3 + 3 design) to determine an acceptable target dose of curcumin with which to safely proceed to a Phase IIa open-labelled randomised controlled trial. Thirty three participants with histological or cytological confirmation of inoperable colorectal cancer will then be randomised to oxaliplatin-based chemotherapy with the addition of daily oral curcumin at the target dose determined in Phase I, or to standard care oxaliplatin-based chemotherapy alone (recruiting at a ratio of 2:1). Discussion: Primary outcome measures will be the determination of a target dose which is both safe and tolerable for long-term administration to individuals in receipt of first-line oxaliplatin-based chemotherapy for inoperable colorectal cancer. Secondary outcome measures will include observation of any changes in neuropathic side-effects of chemotherapy, improvement to progression-free or overall survival and identification of putative efficacy biomarkers in plasma. The results will be disseminated via presentation at national and international conferences, via publication in appropriate peer-reviewed journals and via the Cancer Research UK/Department of Health Experimental Cancer Medicine Centre Network. This trial has full ethical and institutional approval, and commenced recruitment in February 2012. Trial registration: (NCT01490996, registered 7th December 2011), European Drug Regulating Authorities (EudraCT 2011-002289-19, registered 13th May 2011), UKCRN ID#10672.
DOI Link: 10.1186/s13063-015-0641-1
ISSN: 1745-6215
eISSN: 1745-6215
Version: Publisher Version
Status: Peer-reviewed
Type: Journal Article
Rights: © 2015 Irving et al.; licensee BioMed Central. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0) (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.
Appears in Collections:Published Articles, Dept. of Cancer Studies and Molecular Medicine

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