A randomized, controlled, open, multi-center clinical study on the effectiveness and safety of Kangai injection in the treatment of cancer-induced fatigue
- Conditions
- Tumor patients (lung cancer, rectal cancer, malignant lymphoma, gynecological malignancy)
- Registration Number
- ITMCTR2100004974
- Lead Sponsor
- Jiangsu Provincial Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Determined by histopathology or cytology as a tumor patient (lung cancer, rectal cancer, malignant lymphoma, gynecological malignant tumor);
2. Patients receiving chemotherapy;
3. ECOG score 0-1 points;
4. Meet the diagnostic criteria for cancer-related fatigue, and have a fatigue score >=4 (using a 0-10 numerical scale to score the degree of fatigue, 0 = no fatigue, 10 = the most severe fatigue);
5. Age from 18 to 80 years old;
6. Voluntarily sign written informed consent.
1. People with severe mental disorders;
2. People with speech and cognitive impairment;
3. People with allergies or known to be allergic to the drugs and their ingredients used in this test;
4. Patients with abnormal liver and kidney function indexes (ALT, AST, Scr exceed the upper limit of the normal reference range by 1.5 times);
5. Pregnant and lactating women, or women of childbearing age whose blood and/or urine HCG test results are positive before the test;
6. Patients with poor compliance;
7. Other patients who the investigator thinks are not suitable for enrollment.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Piper Fatigue Scale;
- Secondary Outcome Measures
Name Time Method KPS score;Immune function;Quality of life (EORTC-QLQ-C30);Peripheral blood;Incidence of side effects of chemotherapy;