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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• (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.

Locations
Other Locations
China
Hangzhou First People' Hospital
RECRUITING
Hangzhou
Contact Information
Primary
Kaibo Guo
guokaibo@zcmu.edu.cn
+8618072946765
Time Frame
Start Date: 2024-04-30
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 48
Treatments
Experimental: Cangpo Liujun Prescription
Cangpo Liujun Prescription composition: Rhizoma atractylodis 15g, Magnolia officinalis 12g, Tangerine peel 15g, Pinellia pinellia 12g, Codonopsis ginseng 15g, Rhizoma atractylodis macrocephalae 15g, Poria cocos 15g, Honey-fried licorice root 6g. It was taken during and between the treatments, in the morning and in the evening, 200ml each time, for 3 courses, and 1 course was 28 days.
Placebo_comparator: Placebo
Cangpo Liujun Prescription granule mimics was made into a control placebo according to the content of 5% of the treatment group. It was taken during and between the treatments, in the morning and in the evening, 200ml each time, for 3 courses, and 1 course was 28 days.
Related Therapeutic Areas
Sponsors
Leads: First People's Hospital of Hangzhou

This content was sourced from clinicaltrials.gov

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