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.

Conditions

• Colon Cancer

Interventions

DRUG

Tonifying Spleen and Kidney Sequential Regimen

TSKSR will be given to the participants as follows:Liu-jun-an-wei Granule,1 pack each time,twice a day,PO,from 0 to 6th day of chemotherapy and Qi-tu-er-zhi Granule,1 pack each time,twice a day,PO,from 7th to 20th day of chemotherapy.

DRUG

Placebo of 'Tonifying Spleen and Kidney Sequential Regimen

Placebo of TCM-TSKSR will be given to the participants as follows:placebo of Liu-jun-an-wei Granule,1 pack each time,twice a day,PO,from 0 to 6th day of chemotherapy and placebo of Qi-tu-er-zhi Granule,1 pack each time,twice a day,from 7th to 20th day of chemotherapy.

Sponsors & Collaborators

• Beijing University of Chinese Medicine

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• Beijing Chao Yang Hospital

  collaborator OTHER

• Jiangsu Province Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Tianjin Union Medical Center

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Zhengzhou Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Chongqing University Cancer Hospital

  collaborator OTHER

• Civil Aviation General Hospital

  collaborator OTHER

• Xiyuan Hospital of China Academy of Chinese Medical Sciences

  lead OTHER

Principal Investigators

• Yufei Yang, M.D. · Xi-Yuan Hospital, China Academy of Chinese Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-12

Primary Completion

2021-05-31

Completion

2021-05-31

Countries

• China

Study Locations