Abstract
Curcumin is a botanical with anti-tumor and immunomodulatory properties. We hypothesized that curcumin supplementation might influence inflammatory biomarker levels in endometrial carcinoma (EC). In this open-label, non-randomized phase 2 study (NCT02017353), seven EC patients consumed 2 g/day Curcumin Phytosome (CP) orally for 2 weeks. Blood was taken at baseline, days 1, 7, 14, and 21. The following analytes were measured: curcuminoids and metabolites, 56 inflammatory biomarkers, COX-2, frequencies of myeloid-derived suppressor cells, dendritic cells and NK cells, expression of MHC molecules on leukocytes and monocytes and activation/memory status of T cells. Patients completed quality of life (QoL) questionnaires at baseline and end of treatment. Curcumin metabolites were detectable in plasma upon CP intake. CP downregulated MHC expression levels on leukocytes (P = 0.0313), the frequency of monocytes (P = 0.0114) and ICOS expression by CD8+ T cells (P = 0.0002). However, CP upregulated CD69 levels on CD16− NK cells (P = 0.0313). No differences were observed regarding inflammatory biomarkers, frequencies of other immune cell types, T cell activation and COX-2 expression. A non-significant trend to improved QoL was observed. Overall, CP-induced immunomodulatory effects in EC were modest without significant QoL changes. Given the small population and the observed variability in inter-patient biomarker levels, more research is necessary to explore whether benefits of CP can be obtained in EC by different supplementation regimens.Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02017353; www.clinicaltrialsregister.eu, identifier 2013-001737-40.
Highlights
Curcumin is a polyphenol derived from the plant Curcuma longa
Curcumin has been shown to inhibit the accumulation of myeloid-derived suppressor cells (MDSC) and their interaction with cancer cells and induces the differentiation/maturation of MDSC [7]
Curcumin-containing dietary supplements have been used in various clinical trials in cancer or other diseases without major side effects and are generally regarded as safe (GRAS) by the US Food and Drug Administration (FDA)
Summary
Curcumin is a polyphenol derived from the plant Curcuma longa (common name Turmeric). These two components form a non-covalent adduct in a 1:2 ratio, and two parts of microcrystalline cellulose are added to improve formulation, with an overall curcuminoid content of 20% [15] This formulation improves the plasma levels of curcumin and its metabolites [23] and is documented with preclinical and clinical pharmacokinetic studies [23, 24], supported by GLP preclinical safety studies (personal communication with Indena S.p.A., Investigator’s Brochure) and has been used in a number of clinical studies [25,26,27,28]. Curcumin-containing dietary supplements have been used in various clinical trials in cancer or other diseases without major side effects and are generally regarded as safe (GRAS) by the US Food and Drug Administration (FDA) In this phase 2 study, we evaluated the effects of a daily intake of 2 g CP by EC patients during a 2-week, oncological treatment-free interval. The objectives of the study included evaluation of the immunomodulatory effects of CP, bioavailability and impact of the treatment on patient’s quality of life
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