Herbal Treatment to Improve Chemotherapy Delivery

Summary

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.

Timeline

Start

2018-12-12

Primary completion

2021-05-31

Completion

2021-05-31

Publications

• Zhang T, Fei YT, Xu Y, Sun LY, He B, Yan SH, Tang M, Yan YZ, Mao J, Yang YF. Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer: Study Protocol for a Randomized Controlled Trial. Chin J Integr Med. 2021 Dec;27(12):891-895. doi: 10.1007/s11655-021-3448-9. Epub 2021 Aug 25.

Drugs

Indications