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

NCT ID: NCT03245554

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2020-09-01

Brief Summary

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

Conditions

Gastrointestinal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

placebo and propranolol

We used propranolol and placebo as an control drug to treat with patients.

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

placebo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Yijing He

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of Clinical Pharmacology

Changsha, Hunan, China

Countries

China

Central Contacts

Yijing He

Role: CONTACT

yijinghe@gmail.com

+86-1587481262

Other Identifiers

2017 PROP/CSU/GC

Identifier Type: -

Identifier Source: org_study_id