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

BACKGROUND: Curcumin is the main active ingredient of the spice turmeric, investigated extensively for putative anticancer properties. OBJECTIVES: This phase IIa open-labelled randomized controlled trial aimed to assess 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: Twenty-eight patients aged >18 y with a histological diagnosis of metastatic colorectal cancer were randomly assigned (1:2) 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: Addition of daily oral curcumin to FOLFOX chemotherapy was safe and tolerable (primary outcome). Similar adverse event profiles were observed for both arms. In the intention-to-treat population, the HR for PFS was 0.57 (95% CI: 0.24, 1.36; P = 0.2) (median of 171 and 291 d for FOLFOX and CUFOX, respectively) and for OS was 0.34 (95% CI: 0.14, 0.82; P = 0.02) (median of 200 and 502 d for FOLFOX and CUFOX, respectively). There was no significant difference between arms for quality of life (P = 0.248) or neurotoxicity (P = 0.223). 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 (P = 0.712). CONCLUSION: Curcumin is a safe and tolerable adjunct to FOLFOX chemotherapy in patients with metastatic colorectal cancer. This trial was registered at clinicaltrials.gov as NCT01490996 and at www.clinicaltrialsregister.eu as EudraCT 2011-002289-19.

Influence of ethnicity on the perception and treatment of early post-operative pain.

BACKGROUND: Previous studies indicated that patients from Black, Asian and minority ethnic (BAME) groups tend to receive less analgesics compared to Caucasian (White) patients after similar surgical procedures. Most such data originated from North America and suggested that health-care professionals may perceive the expression of excessive pain by BAME patient groups as an exaggerated response to pain, rather than sub-optimal treatment. There are limited data comparing acute pain management between South Asian and White British patients. OBJECTIVE: We aimed to investigate correlation between patients' ethnicity and disparities of early post-operative pain perception/management, in an ethnically diverse population. METHODS: We conducted a retrospective case note review of acute post-operative pain after total abdominal hysterectomy (TAH) in 60 South Asian and 60 age-matched White British females. Data for 140 variables (pre-, intra- and post-operative) for each patient were recorded. We used propensity score matching to produce 30 closely matched patients in each group minimizing effects of recorded co-variates. Data were analysed with and without propensity score matching. RESULTS: There were no significant differences in acute post-operative pain scores, morphine requirements, pain management, adverse effects or duration of post-operative care unit stay between South Asian and White British patients. The median duration of hospital stay of South Asian patients was longer (4.5 days versus 3.0 days, p < 0.001). CONCLUSION: We conclude that in an institution where both patients and health-care professionals are from an ethnically diverse population, neither post-operative pain nor pain management are influenced significantly by South Asian ethnicity.