Clinical Study 4 - Careseng SG2 (HemoMex S) in combination with standard chemotherapy for treatment of breast cancer and ovarian cancer.
- The primary objectives of this study is to determine the efficacy and safety of Careseng SG2 (HemoMex S) in reducing toxicity of chemotherapy agents for the treatment of Breast Cancer and Ovarian Cancer in combination with standard chemotherapy regimens.
- Secondary objectives are:
- To assess the tumor response after 16 weeks of chemotherapy and Careseng SG2 (HemoMex S) treatment.
- To assess the subjects’ Quality of Life.
In this prospective, single-arm study, solid tumor patients administered Careseng SG2 (HemoMex S) along with standard chemotherapy regimens treatment will be compared to retrospective controls that have received only standard chemotherapy regimens treatment. Patients eligible for recruitment into the study will have been diagnosed with Breast Cancer and Ovarian Cancer. Subjects are eligible for primary treatment with chemotherapy (induction chemotherapy) and have an expected survival of at least six month. During the treatment was dynamic research of blood rates (WBC, Platelets, Neutrophils, Haemoglobin), chemistry (AST, ALT, bilrubin, BUN, prothrombin time, creatinine, K+, Na+, Cl-, Ca++ ), tumor markers CA125 for Ovarian cancer patients, CA15-3 for breast cancer patients, CT scan till and after the treatment, ECG, Karnofsky performance status.
Conclusion: Careseng SG2 (HemoMex S) was used in combination with standard chemotherapy regimens in the treatment of solid tumor. Under observation were 40 patients in control and study groups, (25 patients with Breast Cancer and 15 patients with the Ovarian Cancer).
- Out of 40 patients – 1 patient died during the treatment and 39 patients received the full course of the study.
- There was no any patient with allergic response and abdominal disorders.
- Analyzing the results of the treatment of patients with the Breast Cancer was established, that combination of standard chemotherapy regimens with Careseng SG2 (HemoMex S) increases the effect of the treatment 2.5 times.
- The patients with the Ovarian Cancer had the same effect of the treatment in the control and study groups.
- Progressing of the tumor process in control group was more 1-1.5 times then in study group.
- The Careseng SG2 (HemoMex S) improves the tolerance of standard chemotherapy regimens and increases the treatment effect of patients with the Breast Cancer, in particular.