Bowel cancer
Conditions
Interventions
Comprehensive treatment group:CapeOx or FOLFOX combined with Sanghuang compound granules
Western medicine control group:CapeOx or FOLFOX
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) patients with definite pathological diagnosis of colorectal cancer; (2) The western medical diagnosis was in accordance with the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) staging and TNM staging was stage II and high-risk stage III patients see Annex I; (3) 3 weeks to 2 months after radical resection of colorectal cancer; (4) patients did not receive postoperative treatment but were about to receive CapeOx or FOLFOX adjuvant chemotherapy; (5) The age of male and female was between 18 and 75 years old. (6) ECOG score of 0-1; (7) Laboratory data meet the protocol requirements: White blood cell (WBC) = 3.5× 109/L platelet (PLT)= 100× 109/L Hemoglobin (Hb) = 90 g/L total bilirubin (TBIL) =1.5 × ULN; Alanine aminotransferase (ALT)= 2.5 ×ULN serum creatinine (Scr)= 1.5 ×ULN. (8) the expected survival time is more than 6 months; (9) All subjects had normal cognitive function without major organ dysfunction. (10) agreed to abide by the study protocol signed the informed consent and completed the study in accordance with the protocol requirements; (11) Patients agreed not to participate in other intervention studies during the treatment period.
Exclusion criteria
Exclusion criteria: (1) patients with history of other malignant tumors; (2) patients with serious or uncontrolled medical diseases or infection; (3) participating in other clinical research or participating in other clinical research within 1 month; (4) the patient had allergic reaction to the substances in the drug used in the study; (5) The patient had intestinal obstruction and oral drug treatment was ineffective and intravenous high-energy nutrition was needed. (6) The patient suffered from diseases that seriously affected gastrointestinal absorption; (7) pregnant and lactating women; (8) patients with a history of uncontrolled mental illness; (9) patients treated with radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of cancer-related fatigue;Completion rate of chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality-of-life SCORES;Disease free survival, recurrence and metastasis time, recurrence and metastasis rate;Immune function;Traditional Chinese Medicine syndrome score;Tumor markers;Measures OF SAFETY; | — |
Countries
China
Contacts
Public ContactZhenye Xu and Limin Zhu
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed