Herbal Treatment to Improve Chemotherapy Delivery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colon Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
CapeOX chemotherapy is a combination therapy of Oxaliplatin 130mg/m^2 IV on 1st day and Capecitabine 1000mg/m^2 PO twice daily from 1th day to 14th day,21 days for each course of treatment.Adverse effects of chemotherapy,such as myelosuppression and gastrointestinal reactions,may lead to dose reduct...
CapeOX chemotherapy is a combination therapy of Oxaliplatin 130mg/m^2 IV on 1st day and Capecitabine 1000mg/m^2 PO twice daily from 1th day to 14th day,21 days for each course of treatment.Adverse effects of chemotherapy,such as myelosuppression and gastrointestinal reactions,may lead to dose reductions,treatment delays or even discontinuation among cancer patients. According to IDEA study,the completion rate of 8-cycle CapeOX chemotherapy in colorectal cancer patients is 64%,which means that nearly 4 in 10 patients could not complete adjuvant chemotherapy as planned,which may negatively impact patients' survival outcomes.Some prior studies have shown that TCM can improve patients' symptom control and QoL during adjuvant chemotherapy,which may further improve the completion of adjuvant chemotherapy. However,there is a lack of definitive evidence to evaluate the effects of TCM in stage II(high-risk)& III colon cancer patients who receive adjuvant chemotherapy after radical surgery.The study will be conducted between 2018 and 2021.Four hundred participants will be enrolled and randomly assigned to either the experimental group or the control group.
Tracking Information
- NCT #
- NCT03716518
- Collaborators
- Jiangsu Province Hospital of Traditional Chinese Medicine
- Beijing University of Chinese Medicine
- Peking University Third Hospital
- Beijing Chao Yang Hospital
- Shanghai Zhongshan Hospital
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Tianjin Union Medical Center
- Henan Provincial People's Hospital
- Zhengzhou Hospital of Traditional Chinese Medicine
- Beijing Cancer Hospital
- Chongqing University Cancer Hospital
- Civil Aviation General Hospital
- Investigators
- Principal Investigator: Yufei Yang, M.D. Xi-Yuan Hospital, China Academy of Chinese Medical Sciences