Spots Global Cancer Trial Database for Herbal Treatment to Improve Chemotherapy Delivery
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Trial Identification
Brief Title: Herbal Treatment to Improve Chemotherapy Delivery
Official Title: Effect of TCM-TSKSR on Completion Rates of Chemotherapy in Patients With Stage II & III Colon Cancer: A Randomized Placebo-Controlled Clinical Trial
Study ID: NCT03716518
Conditions
Study Description
Brief 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.
Detailed 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 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Chao Yang Hospital, Beijing, Beijing, China
Civil Aviation General Hospital, Beijing, Beijing, China
Oncology Department of Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
Chongqing University Cancer Hospital, Chongqing, Chongqing, China
Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangdong, Guangzhou, China
The Third People's Hospital of Zhengzhou, Zhengzhou, Henan, China
Henan Provincial People's Hospital, Zhengzhou, Henan, China
Zhengzhou Hospital of Traditional Chinese Medicine, Zhengzhou, Henan, China
Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing, Jiangsu, China
Shanghai Zhongshan Hospital, Shanghai, Shanghai, China
Tianjin Union Medical Center, Tianjin, Tianjin, China
Contact Details
Name: Yufei Yang, M.D.
Affiliation: Xi-Yuan Hospital, China Academy of Chinese Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
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