This study is designed to:(1) determine the efficacy of Traditional Chinese Medicine (TCM)
'Tonifying Spleen and Kidney Sequential Regimen' (TSKSR) in improving the completion rate of
8-cycle CapeOX chemotherapy in patients with stage II (high-risk)& III colon cancer;(2)
evaluate the efficacy of the TCM-TSKSR on adverse events of CapeOX chemotherapy and it's
impact on patients' quality of life (QoL).A randomized,double-blinded,placebo-controlled
clinical trial including seven centers will be conducted in Mainland China.The study will
enroll patients with stage II (high-risk)& III colon cancer who have completed radical
surgery and are going to receive CapeOX chemotherapy.All participants will receive
chemotherapy as prescribed by their treating physicians and be randomly assigned to either
concurrent use of TCM-TSKSR or placebo.
Phase:
Phase 3
Details
Lead Sponsor:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators:
Beijing Cancer Hospital Beijing Chao Yang Hospital Beijing University of Chinese Medicine Chongqing University Cancer Hospital Civil Aviation General Hospital Guangdong Provincial Hospital of Traditional Chinese Medicine Henan Provincial People's Hospital Jiangsu Province Hospital of Traditional Chinese Medicine Peking University Third Hospital Shanghai Zhongshan Hospital Tianjin Union Medical Center Zhengzhou Hospital of Traditional Chinese Medicine