Clinical Research on Teratment of Gastrointestinal Cancer in the Preoperative by Propranolol

Gastrointestinal Cancer Clinical Trial

Official title:

Clinical Research on Teratment of Gastrointestinal Cancer in the Preoperative by Propranolol

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03245554
• Other study ID #: 2017 PROP/CSU/GC
• 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
• 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.

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

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.