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

Primary Purpose

Gastrointestinal Cancer

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Propranolol
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Cancer focused on measuring Gastrointestinal Cancer, Propranolol

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Clinical Pharmacology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

placebo and propranolol

Arm Description

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

Outcomes

Primary Outcome Measures

Tumor size will be measured.
We used CT and Ki67 to confirm that the drug's affection.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2017
Last Updated
April 6, 2018
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT03245554
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Anticipated)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer
Keywords
Gastrointestinal Cancer, Propranolol

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo and propranolol
Arm Type
Experimental
Arm Description
We used propranolol and placebo as an control drug to treat with patients.
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tumor size will be measured.
Description
We used CT and Ki67 to confirm that the drug's affection.
Time Frame
Our experiment completed after patients took medicine for one week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with gastric adenocarcinoma and colon cancer were diagnosed by histology and cytology, and there was a clear metastasis (TxNxM0); 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. the age range of the patients is 18-60; systolic pressure 100-140mmHg; heart rate >60bpm; the patient's survival time should be longer than 3 months; without previous cardiovascular and cerebrovascular diseases, the atrioventricular block was excluded by the 24 hour dynamic electrocardiogram; 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); 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; have the ability to understand and sign informed consent. Exclusion Criteria: pregnant or lactating women; 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. patients with epilepsy or psychotropic drugs and sedatives; patients with brain metastasis and bone marrow metastasis; participants in clinical trials of other drugs within 4 weeks; patients with a history of anaphylaxis with propranolol; patients treated with trastuzumab; patients with or reactive immunodeficiency, such as those with HIV infection; 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; patients with atrioventricular block should be discontinued immediately and quit; the researchers believe there may be any increase in the risk of the subject or any interference with clinical trials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yijing He
Phone
+86-1587481262
Email
yijinghe@gmail.com
Facility Information:
Facility Name
Institute of Clinical Pharmacology
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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