Colorectal Cancer
Conditions
Interventions
Observation Group:Changfukang Granules, 1 sachet each time, twice daily, to be taken orally. The treatment course is three months, followed by a three-month follow-up (with follow-ups conducted at the
?control group?:Conventional Western medicine treatment
Sponsors
The Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1)Pathologically confirmed colorectal cancer; 2) Meeting the traditional Chinese medicine (TCM) syndrome differentiation of spleen deficiency with blood depletion and stasis-toxin accumulation; 3) Willing to receive Changfukang Granule treatment; 4) No other serious comorbidities; 5) Age 18-80 years, regardless of gender; 6) ECOG score = 2 with an expected survival period of = 3 months; 7) Baseline laboratory tests meeting the following criteria: neutrophil count = 1.5 × 10^9/L, platelet count = 70 × 10^9/L, hemoglobin = 9.0 g/dL, serum aspartate aminotransferase (AST) = 5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) = 5 times ULN, serum creatinine = 1.5 times ULN.
Exclusion criteria
Exclusion criteria: Patients with severe hepatic and renal dysfunction (severe hepatic dysfunction is defined as ALT > 2 times the Upper Limit of Normal (ULN) or AST > 2 times ULN; severe renal dysfunction is defined as serum creatinine (Cr) > 1.5 times ULN). Patients with severe pulmonary dysfunction, as defined by the following criteria [FEV1 percentage of predicted value (including obstructive or restrictive disorders): Severe: 35%–49%; Very Severe: < 35%; or DLCO percentage of predicted value: < 40%].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?TCM syndrome;cardinal symptom;tongue coating;pulse manifestation; | — |
Secondary
| Measure | Time frame |
|---|---|
| ?physical sign?;Karnofsky Performance Status Scale;Eastern Cooperative Oncology Group Performance Status; | — |
Countries
China
Contacts
Public ContactQiMei Wang
The Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine
Outcome results
None listed