Inositol hexaphosphate (IP6) is a naturally occuring polyphosphorylated carbohydrate, present in almost all plant and mammalian cells, where it is important in regulating vital cellular functions such as signal transduction, cell proliferation and differentiation [3, 4]. For a long time, IP6 has been recognized
as a strong antioxidant. Recently, a striking anticancer effect of IP6 was demonstrated in different experimental models [3–14]. Inositol is also a natural constituent possesing moderate anticancer activity [3, 4]. However, it was shown that inositol potentiates NVP-HSP990 mouse both the antiproliferative and antineoplastic effects of IP6 in vivo, and that the AZD9291 in vitro combination of IP6 and inositol was significantly better in different cancers (colon, breast and metastatic lung cancer model) than was either one alone [3, 4]. Due to its strong antioxidant activity, and health beneficial effects, such as immune stimulation, prevention of kidney stone formation and hypocholesterolemic effect, IP6 + Inositol is available as dietary supplement. Current cancer treatment recognizes the importance of combination therapy in order to increase efficacy and decrease side effects of conventional chemotherapy. It has been shown in vitro that IP6 acts synergistically with doxorubicin and
tamoxifen, being particularly effective against estrogen receptor-negative and doxorubicin-resistant breast cancer cell lines . Furthermore, several case studies have shown that when NCT-501 clinical trial IP6 and inositol were given in combination with chemotherapy, side effects of chemotherapy were diminished and patients were able to perform their daily activities [16–18]. Based on these properties, this study has been Clomifene designed to evaluate in a small controlled clinical trial if the combination of IP6 + Inositol and traditional chemotherapy will increase efficacy and decrease side effects of chemotherapy, and in particular if the IP6 + Inositol will be able to improve the quality of life in patients undergoing the treatment for breast cancer. Materials and methods Study Population In order to
test the effectiveness of IP6 + Inositol in improving the quality of life of patients who are treated for breast cancer, we have conducted a prospective, randomized, controlled clinical study with the tested (IP6 + Inositol Group) and control (Placebo Group) groups of patients. This study was approved by the ethics committee of the General Hospital, Zadar. Written informed consent was obtained from all participants. The study included 14 patients with ductal invasive breast cancer subjected to surgery and with histological features and stage of tumor that indicated polychemotherapy. All patients received the FEC polychemotherapy protocol in six cycles. Patients receiving neoadjuvant chemotherapy were not included in the study. Tested group consisted of 7 patients, average age 56 years (26-76), who were given IP6 + Inositol (IP6 International Inc.