This study is designed as a multi-center, randomized, double-blind, placebo-controlled trial. Subjects in the intervention group will be treated with XLJDOD compound granule. Subjects in the control group will be treated with placebo (XLJDOD mimetic agent).
Subjects in the intervention group will be treated with XLJDOD compound granule. Treatment will begin within 3 months after standard adjuvant chemotherapy and compliance will be continuously monitored. XLJDOD will be taken twice a day, infused with warm water, 1 hour after lunch and dinner. One course of treatment will take 28 days in 1 month, and 2- to 3-day rest. Treatment will continue for 6 courses. Subjects in the control group will be treated with placebo (XLJDOD mimetic agent). The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
730
Treatment will begin within 3 months after standard adjuvant chemotherapy and compliance will be continuously monitored. XLJDOD will be taken twice a day, infused with warm water, 1 hour after lunch and dinner. One course of treatment will take 28 days in 1 month, and 2- to 3-day rest. Treatment will continue for 6 courses.
The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.
Jiangsu Province Hospital of Traditional Chinese Medicine
Nanjing, China
RECRUITINGTwo-year disease-free survival (DFS)
2-year DFS is defined as the percentage of patients alive without disease recurrence at 2 years measured from the randomization date.
Time frame: Assess once 24 months after randomization
Three-year disease-free survival (DFS)
3-year DFS is defined as the percentage of patients alive without disease recurrence at 3 years measured from the randomization date.
Time frame: Assess once 36 months after randomization
One, two, three-year relapse rate (RR)
RR is defined as the fraction of followed patients who have disease recurrence. All disease recurrences and deaths from colon cancer are events. Second primary same cancers and other primary cancers will be ignored.
Time frame: Assess at month 12, 24, 36 after randomization
Three-year survival rate
3-year survival rate is defined as the percentage of patients alive at 3 years measured from the randomization date.
Time frame: Assess once 36 months after randomization
Overall survival (OS)
OS is measured from the date of enrollment to the date of death, irrespective of cause.
Time frame: Observation to the end of the study,assessed up to 24 months
Changes in total score on the EORTCQLQ-C30 Scale
The changes of The European O-rganization for Reasearch and Treatment of Cancer score will be compared in the two groups prior to and following XLJDOD compound granule administration. It is a universal scale for all patients with malignant tumors with a total score of 126, ranging from 30 (least severe) to 126 (most severe).
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Time frame: Measurement will be performed at baseline and month 6, 12 ,18 ,24, 36.
Changes in total score on the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM)
The scale is divided into two parts. The first part mainly assesses the severity of 20 common clinical symptoms and TCM-related symptoms of patients with cancer in the past 24 hours. The second part is the evaluation scale of the interference of the above symptoms with daily functioning. It has a total of 26 items, each with a score of 0-10, leading to a total score of 0-260.
Time frame: Compared with the baseline period, the changes in MDASI-TCM score at month 6, 12 ,18 ,24, 36 will be measured.