Radiotherapy plays an important role in cancer therapy. Most of the early stages of cancer with curative radiotherapy can achieve up to 90% of a 5-year survival rate. Even for patients at late stage, their symptoms also can be relieved. Every radiotherapy and chemotherapy has the potential to cause harm and produce toxicity such as weakness, tired, anorexia nervosa, dry mouth. With the early research, we find that SMD-2 can relieve the symptoms of weakness, tired, anorexia nervosa, dry mouth. Furthermore, we have also found out that the cancer patients who are receiving the therapy of San-Huang-Hsien-Hsin Tang (Year 2002) and SMD-2 (Year 2009), shows an inverse ratios between the quality of life and trace elements Cu/Zn and Cu/Se in urine. So we are interested to probe into the mechanism of SMD-2 on this research. The present phase II RCT clinical study is to evaluate the effects of SMD-2 in the head & neck cancer patients receiving the radiotherapy and chemotherapy, especially examinate their characteristic of TCM constitution, prosecute the TCM differentiation of syndrome, and analyze the distribution of TCM syndrome differentiation in cancer patients between SMD-2 group and control group for two years. Survival and mortality will also be evaluate at the same time. In addition, we are going to assess the clinical evaluation among the ratio of trace elements Cu/Zn and Cu/Se in blood during treatment, and to estimate the quality of life (EORTC: QLQ-C30) and body constitution (BCQ) during the period of radiotherapy and chemotherapy on the basis of Chinese Medicine Theory. To prove the efficacy of SMD-2 in human body, we have further in vitro/in vivo experiment to evaluate the mechanisms of SMD-2 on SCC-4 & Cal-27 cell-line and mice’s immune modulation during the second year.
