Study on the Curative Effect of Cangpo Liujun Prescription on Cancer-related Fatigue in Patients With Advanced Colorectal Cancer Undergoing Second-line Chemotherapy With Spleen Deficiency and Dampness Excess and Analysis of Intestinal Flora

CPLJF

The goal of this clinical trial is to learn if Cangpo Liujun Prescription works to treat cancer-related fatigue in patients with advanced colorectal cancer undergoing second-line chemotherapy with spleen deficiency and dampness excess. It will also learn about the safety of Cangpo Liujun Prescription. The main questions it aims to answer are: Does Cangpo Liujun Prescription improve the fatigue symptoms for participants? How about the relationship between taking Cangpo Liujun Prescription and distribution of intestinal flora? Researchers will compare Cangpo Liujun Prescription to a placebo (a look-alike substance that contains no drug) to see if Cangpo Liujun decoction works to treat cancer-related fatigue in patients with advanced colorectal cancer undergoing second-line chemotherapy with spleen deficiency and dampness excess. Participants will: Take Cangpo Liujun Prescription or a placebo every day for 3 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms Take blood samples to detect immune function and inflammatory factors Collected Feces for gut microbiota analysis

2024-04-30

2025-04-01

2026-04-01

Recruiting

Early phase I

48

Inclusion Criteria: (1) Diagnosis of stage IV colorectal cancer: confirmed by pathology or cytology; (2) Second-line treatment; (3) Clinical diagnosis of cancer-related fatigue; (4) Traditional Chinese medicine syndrome differentiation with spleen deficiency and damp excess; (5) PS score ≤2; (6) Age of 18-75 years old; (7) Predicted survival time ≥3 months; (8) Without other serious complications; (9) Non-pregnant and lactating patients; (10) Without allergic reaction to the ingredients in the prescription; (11) Agreed to participate in the study after informed consent, signed the informed consent form, and had good compliance. Exclusion Criteria: 1) Conditions that may prevent the subjects from completing the clinical trial process, including but not limited to serious and difficult to control organic lesions or infection, heart failure, etc.; Patients with severe liver and kidney dysfunction (serum creatinine ≥1.5 times ULN; ALT or AST≥5 times ULN; Bilirubin ≥1.5 times ULN); (2) Combined with hematopoietic system diseases, such as anemia, requiring anemia correction drugs; (3) Receiving or preparing to receive treatment that may affect CRF; (4) Taking other drugs that may improve CRF; (5) Combined with tumors of other systems; (6) Mental illness or lack of independent behavior ability; (7) Cooperate with the investigators to complete the clinical investigation; (8) Pregnant, preparing to become pregnant or lactating women; (9) Participating in other clinical trials or have participated in other clinical trials within 3 months; (10) Alcohol and/or psychoactive substances, substance abusers and addicts; (11) According to the investigator's judgment, other lesions or conditions that may reduce or complicate the possibility of enrollment, such as frequent changes in work environment, unstable living environment, and other conditions that may cause loss to follow-up.

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2024-05-01