Combining curcumin (C3 complex, Sabinsa) with standard care FOLFOX chemotherapy in patients with inoperable colorectal cancer (CUFOX): study protocol for a randomised control trial
Trials 2015. DOI: 10.1186/s13063-015-0641-1
|In Western set-up colorectal cancer—the 4th most common cancer |
worldwide—associated with second-most cancer-related mortality with nearly 1 in 15 incidences in a lifetime. It has been reported that 1/5th of colorectal cancer patients will be having metastatic disease, predominantly in liver and around 50% of these develop metastases when undergone resection for primary disease.
The FOLFOX (oxaliplatin, 5-fluorouracil and folinic acid) therapy has been the first choice of chemotherapy in such patients, which is relatively well tolerated in comparison to other cytotoxic regimens. However, FOLFOX does suffer from some limitations (e.g. diarrhoea due to mucositis—a life threatening condition). Peripheral sensory neuropathy has also been experienced by most of patients (90%) because of oxaliplatin.
Hence, in recent times several possibilities have been explored to overcome chemo-resistance and/or augmenting the action of FOLFOX therapy so that patients can tolerate the therapy better, delay the resistance and without toxicity.
Thus, naturally available dietary agents like Curcumin, which has been known for its anticancer potential since ancient time, is drawing attention to address the above mentioned issues. Curcumin has become the most attractive due to its better safety, tolerability and no side effects.
This randomized, controlled clinical study will be evaluating the effects of CUFOX (Curcumin and FOLFOX) regimen on the colon cancer subjects.
The patients with colorectal cancer and have inoperable liver metastasis will be recruited. Median survival for patients in unresectable colorectal liver metastases with chemotherapy for only 24 months will be the inclusion criteria. The product of choice for this clinical trial is Curcumin C3 Complex® from Sabinsa Corporation.
This study will be conducted in Phase I (dose-escalation study for CUFOX) and Phase II randomized, controlled trial combining Curcumin and FOLFOX in patients with diagnosis of metastasis colorectal cancer. As the side effects of this combination are unknown, a dose-escalation study will be planned as mentioned above. Curcumin will be administered in a dosage of 0.5–2.0 g per day. The target dosage of Curcumin has been chosen based on the compliance from a pilot study, further in an animal model study, polyp prevention demonstrating efficacy for Curcumin proposes use of 1.6 g per day delivered in a single dosage in human.
The primary endpoints in this clinical study will be to measure safety and tolerability of the FOLFOX-Curcumin combination.
This will be the first clinical trial to investigate the outcomes from the combination of oral Curcumin with standard care oxaliplatin-based chemotherapy. This clinical trial is a first randomized trial of its kind and results of this trial can provide early evidence of clinical efficacy of Curcumin within the chemotherapeutic setting.