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., Melbourne, FL, USA) per os in the form of powder in the daily dosage of 6 g, divided in 2 doses, starting from the first postoperative day, every day until the end of treatment (6 months). The control group consisted of 7 patients, who were treated for ductal invasive breast cancer of the same characteristics as the tested group. The control group was given placebo (Vitamin C) of the same look and consistency as IP6 + Inositol, in the same dosage (6 g) until the end of treatment (6 months).
Study Procedures
At the end of treatment, all patients have filled the questionnaires QLQ-30 and QLQ-BR23 from European organization for testing the treatment of cancer (EORTC) [19, 20]. The questions in questionnaire were divided into two scales, the functional and symptomatic.
Functional scale contains questions about the physical, emotional, cognitive, social and sexual functions. Each group has a range of responses matching from 0-100, where 100 represents the maximum compatibility with the offered answers, and 0 represents the complete lack of compatibility.
Symptomatic scale contains questions about side effects of treatment, such as the general bad condition, nausea, vomiting, diarrhea, constipation, pain, insomnia, loss of appetite, loss of body weight, hair loss, increase body temperature and the operating complications of treatment. Replies from symptomatic scale are evaluated with the scale from 0-100, where 100 represents maximally positive personal experience with total quality of life, and 0 represents maximally negative personal experience of the quality of life.
Both groups of patients were monitored with the following laboratory parameters: total blood cell counts (TBC), CEA, CA 15-3, LDH, AST, ALT, AP, bilirubin, urea, creatinin and electrolytes. The testing was done at the first day of therapy, a month after, and at the the end of treatment.
For the processing of data obtained from the questionnaires, the QLQ-C30 SC (scoring manual), also produced by EORTC was utilized. The results were tested for significancy with the Student t-test for small samples (dependents and independents), and the p value of < 0.05 was considered significant.