Colorectal Cancer
Conditions
Keywords
colorectal cancer, traditional Chinese medicine
Brief summary
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
Detailed description
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.
Interventions
once a day in the morning and evening, every month for a course of treatment, a total of three courses
Sponsors
Chinese Academy of Medical Sciences
Tianjin People's Hospital
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
This study was double-blind. According to the randomized results, the experimental group was given orally therapeutic granules, while the control group was given orally low-dose granules. Random sequence was generated by professional statisticians of group leader unit by statistical software. 350 subjects were divided into experimental group and control group according to the ratio of 1:1, 175 cases in each group. Random seeds and random sequences are stored as confidential data in opaque envelopes, and emergency envelopes are handed over to a third party to ensure that patients, researchers and outcome evaluators are unaware of the patient group before blindness is uncovered. After successful screening and signing the informed consent form, the patient can open a random envelope in turn and record the subject's name, hospital number and admission time on the envelope.
Intervention model description
This study was double-blind. According to the randomized results, the experimental group was given orally therapeutic granules, while the control group was given orally low-dose granules.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria； 2. Radical resection of colorectal cancer was performed and adjuvant chemotherapy (based on 5-FU regimens for at least 3 months) was completed within 3 months of the end of chemotherapy； 3. Tumor Node Metastasis(TNM) stage is high-risk II stage and III stage； 4. Age 18-80 years, sex unlimited； 5. No recurrence or metastasis by imaging or doctor's clinical judgement； 6. Signed informed consent； Note \* According to National Comprehensive Cancer Network(NCCN )clinical guidelines: Phase II:T3-4N0M0; High-risk Phase II is defined as follows:：a.T4;b. Less than 12 lymph nodes were detected；c. preoperative intestinal obstruction, perforation of tumor site；d. poor histological differentiation (except highly unstable microsatellite)；e. neurological invasion and vascular tumor thrombus； f. positive or unknown margin, and insufficient margin safety distance. Phase III：T1-4N1-2M0.
Exclusion criteria
1. History of previous or combined malignancies except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix； 2. Combined with severe heart, liver and kidney disease； 3. Any unstable condition or condition that may endanger patient safety and compliance with research, such as pregnancy, depression, manic-depressive disorder, obsessive-compulsive disorder, or schizophrenia; 4. The researchers determine that they were not suitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival time | 3 years | from the date of radical resection of colorectal cancer to the time of recurrence or metastasis. |
| Metastasis recurrence rate in 1 year | 1 year | The ratio of metastasis and recurrence to the patients was observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Edmonton Symptom Assessment Scale( ESAS ) | 3months | 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 |
| Traditional Chinese Medicine(TCM )symptom grading table | 3 months | 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% |
| Metastasis recurrence rate in 3 years | 3 years | The ratio of metastasis and recurrence to the patients was observed. |
| Metastasis recurrence rate in 2 years | 2 years | The ratio of metastasis and recurrence to the patients was observed. |
| Functional Assessment of Cancer Therapy-Colorectal (FACT-C) scale | 3 months | 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.) |
Countries
China
Contacts
Primary Contactyu wu, master
Backup Contactliusheng li, doctor
Outcome results
None listed