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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03245554
Other study ID # 2017 PROP/CSU/GC
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received August 7, 2017
Last updated April 6, 2018
Start date May 1, 2018
Est. completion date September 1, 2020

Study information

Verified date April 2018
Source Central South University
Contact Yijing He
Phone +86-1587481262
Email yijinghe@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date September 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Propranolol
0 or 1 were generated by using Random software. The patient entered the placebo group if number was 0; if the random number generated was 1, then entered the propranolol group.

Locations

Country Name City State
China Institute of Clinical Pharmacology Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor size will be measured. We used CT and Ki67 to confirm that the drug's affection. Our experiment completed after patients took medicine for one week.
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