Clinical trial NCT03245554: Clinical Research on Teratment of Gastrointestinal Cancer in the Preoperative by Propranolol
Official title: Clinical Research on Teratment of Gastrointestinal Cancer in the Preoperative by Propranolol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Gastrointestinal Cancer
Keywords: Gastrointestinal Cancer
Propranolol
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To research the effect of propranolol on the proliferation and apoptosis of gastrointestinal cancer.


Eligibility criteria: Inclusion Criteria:

1. patients with gastric adenocarcinoma and colon cancer were diagnosed by histology and cytology, and there was a clear metastasis (TxNxM0);
2. without any prior treatment (including surgery or radiotherapy and chemotherapy) in the I-III period, no distant metastasis, suitable for patients with surgical resection of the tumor.
3. the age range of the patients is 18-60;
4. systolic pressure 100-140mmHg; heart rate \>60bpm;
5. the patient's survival time should be longer than 3 months;
6. without previous cardiovascular and cerebrovascular diseases, the atrioventricular block was excluded by the 24 hour dynamic electrocardiogram;
7. ECOG score of 2 (that means the patient's bed time is less than 50%); Karnofsky score of 60% (that means patients have the basic activities and self-care ability);
8. the basic biochemical examination results of patients with normal: white blood cell 3000/ul; neutrophil 1500/ul 100000/ul; platelet count; total bilirubin \< 1.5 x ULN; AST / ALT 2.5 x ULN without liver metastasis; \< 5 x ULN liver metastasis; creatinine clearance rate of 1.5 x ULN;
9. have the ability to understand and sign informed consent.

Exclusion Criteria:

1. pregnant or lactating women;
2. patients with severe heart disease, kidney disease, metabolic disorders, bronchial asthma, cardiogenic shock, heart block (II-III degree atrioventricular block), or severe acute heart failure, sinus bradycardia.
3. patients with epilepsy or psychotropic drugs and sedatives;
4. patients with brain metastasis and bone marrow metastasis;
5. participants in clinical trials of other drugs within 4 weeks;
6. patients with a history of anaphylaxis with propranolol;
7. patients treated with trastuzumab;
8. patients with or reactive immunodeficiency, such as those with HIV infection;
9. the uncontrollable situation in the group during the period (but not limited to these cases): according to the experimental scheme of medication, severe infection, due to mental illness or other social factors lead to the compliance requirements of patients;
10. patients with atrioventricular block should be discontinued immediately and quit;
11. the researchers believe there may be any increase in the risk of the subject or any interference with clinical trials.

Primary outcomes:
measure: Tumor size will be measured.
timeFrame: Our experiment completed after patients took medicine for one week.
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Institute of Clinical Pharmacology
state: Hunan
Study officials:
References: