Clinical effects of Xingxiao Pill in the treatment of cancer

Phase 1

Recruiting

• Conditions: cancer

• Registration Number: ITMCTR2000004184
• Lead Sponsor: Dongfang Hospital, Beijing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Patients will be diagnosed as malignant tumors with cytological or histopathological diagnosis , including respiratory tract tumors, gastrointestinal tumors and reproductive system tumors;
2) Patients who have received chemotherapy in the past 1 month;
3) Aged >= 18 years;
4) Eastern Cooperative Oncology Group (ECOG) score <= 2 and estimated survival time > 1 month;
5) Have certain reading ability;
6) Voluntarily agree to participate in this study and sign the informed consent.

Exclusion Criteria

1) Hyperthermia occurs within two weeks with a body temperature of more than 38 degrees C, or there is obvious active infection;
2) Significant cardiovascular abnormalities (e.g., myocardial infarction, superior vena cava syndrome, grade 2 or above heart disease or uncontrolled hypertension before enrollment (systolic blood pressure over 160 mmHg or diastolic blood pressure over 100mmHg);
3) Serum bilirubin is 1.5 times higher than the upper limit of the reference range of normal value;
4) The serum myoliver is 1.5 times higher than the upper limit of the reference range of normal value or myoliver clearance rate < 50 ml/min;
5) ALT or AST > in the absence of liver metastasis; 2.5 times the upper limit of the normal value, or 5 times the upper limit of the reference range of ALT or AST in the case of liver metastasis;
6) Pregnant or lactating women;
7) Persons with mental illness or intellectual or language impairment;
8) Patients who are known to be allergic to the components used in the study;
9) Patients who are participating in other drug trials within the past month or so;

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TCM syndrome score and chills and fever constitution scale;

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate;stool routine test;electrocardiogram;Blood coagulation;blood routine examination;Quality of Life scale;Biochemical;routine urine test;tumor CT enhancement;