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

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ClinicalTrials.gov Identifier: NCT03245554
Recruitment Status : Not yet recruiting
First Posted : August 10, 2017
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Yijing He, Central South University

Tracking Information
First Submitted Date  ICMJE August 7, 2017
First Posted Date  ICMJE August 10, 2017
Last Update Posted Date April 9, 2018
Estimated Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2017)
Tumor size will be measured. [ Time Frame: Our experiment completed after patients took medicine for one week. ]
We used CT and Ki67 to confirm that the drug's affection.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03245554 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Research on Teratment of Gastrointestinal Cancer in the Preoperative by Propranolol
Official Title  ICMJE Clinical Research on Teratment of Gastrointestinal Cancer in the Preoperative by Propranolol
Brief Summary To research the effect of propranolol on the proliferation and apoptosis of gastrointestinal cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastrointestinal Cancer
Intervention  ICMJE 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.
Other Name: placebo
Study Arms  ICMJE Experimental: placebo and propranolol
We used propranolol and placebo as an control drug to treat with patients.
Intervention: Drug: Propranolol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yijing He +86-1587481262 yijinghe@gmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03245554
Other Study ID Numbers  ICMJE 2017 PROP/CSU/GC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yijing He, Central South University
Study Sponsor  ICMJE Central South University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Central South University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP