Cangpo Liujun Prescription for Cancer-related Fatigue in Advanced Colorectal Cancer
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
This study is testing if a traditional Chinese medicine called Cangpo Liujun Prescription can help reduce cancer-related fatigue in patients with advanced colorectal cancer who are receiving chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | First People's Hospital of Hangzhou Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06394128 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Cangpo Liujun Prescription in alleviating cancer-related fatigue in patients with advanced colorectal cancer who are undergoing second-line chemotherapy. Participants will receive either the Cangpo Liujun Prescription or a placebo daily for three months, with bi-weekly clinic visits for assessments. The study will also investigate the safety of the prescription and its impact on intestinal flora distribution. The trial focuses on patients diagnosed with spleen deficiency and dampness excess, a specific traditional Chinese medicine syndrome. By comparing the treatment to a placebo, researchers hope to determine the prescription's efficacy in improving fatigue symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with stage IV colorectal cancer experiencing cancer-related fatigue and diagnosed with spleen deficiency and dampness excess.
Not a fit: Patients with severe organ dysfunction or other serious complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from cancer-related fatigue.
How similar studies have performed: While studies on cancer-related fatigue exist, the specific use of Cangpo Liujun Prescription in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- Hangzhou First People' Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Kaibo Guo
- Email: guokaibo@zcmu.edu.cn
- Phone: +8618072946765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.