This study will take disease-free survival time and recurrence and metastasis rate as the main evaluation indexes, to evaluate the clinical efficacy of strengthening the spleen and reducing phlegm method in patients with stage II high-risk and stage III colorectal cancer
The study enrolled 350 patients with stage II high-risk and stage III colorectal cancer who underwent adjuvant chemotherapy (based on a 5-fluorouracil(5-FU) regimen for at least 3 months) and patients who received chemotherapy for less than 3 months. The study will use a large sample, multicenter, randomized, double-blind study. The experimental group was given oral Jianpi Huatan dispensing granule, once a day in the morning and evening, 1 course per 1 month, a total of 3 courses; the control group of oral Chinese medicine formula low dose control granules (including the test group dose 1 /10), 1 time each morning and evening, 1 course per month, for a total of 3 courses. The patients were followed up once a month during the treatment period and once every 3-6 months after the end of treatment until the patient relapsed, died or the study was over.Some patients in the study will be tested for circulating tumor cells. Main outcome measures is Disease-free survival time(DFS)and Metastasis recurrence rate in 1 year;Secondary outcome measures:Quality of life score: applied quality of life scale.Metastasis recurrence rate in 2、3years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
350
once a day in the morning and evening, every month for a course of treatment, a total of three courses
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Disease-free survival time
from the date of radical resection of colorectal cancer to the time of recurrence or metastasis.
Time frame: 3 years
Metastasis recurrence rate in 1 year
The ratio of metastasis and recurrence to the patients was observed.
Time frame: 1 year
Traditional Chinese Medicine(TCM )symptom grading table
Effective: after treatment, TCM symptom score decreased by more than 50% compared with that before treatment. Effective: decrease \< 50% and equal to 30%; Invalid: decrease \< 30%. Note: the formula is: (before treatment - integral after treatment) / before treatment by 100%
Time frame: 3 months
Functional Assessment of Cancer Therapy-Colorectal (FACT-C) scale
The FACT-C scale was divided into five grades: none (0), one point (1), some (2), equivalent (3) and very (4). The positive items (i.e. the higher the grade, the better the quality of life.)
Time frame: 3 months
Edmonton Symptom Assessment Scale( ESAS )
The scale used digital scoring method, each symptom scoring range of 0-10 points, 0 points for asymptomatic, 10 points for the most serious degree imaginable, patients choose a number to express their subjective feelings, the larger the number indicates the more serious the symptoms. 1\~10 points were divided into 3 degrees, mild, moderate and severe. 1\~3 were mild, 4\~6 were moderate, and 7\~10 were severe
Time frame: 3months
Metastasis recurrence rate in 2 years
The ratio of metastasis and recurrence to the patients was observed.
Time frame: 2 years
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Metastasis recurrence rate in 3 years
The ratio of metastasis and recurrence to the patients was observed.
Time frame: 3 years