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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

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

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Drug: Propranolol Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Research on Teratment of Gastrointestinal Cancer in the Preoperative by Propranolol
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: placebo and propranolol
We used propranolol and placebo as an control drug to treat with patients.
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245554


Contacts
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Contact: Yijing He +86-1587481262 yijinghe@gmail.com

Locations
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China, Hunan
Institute of Clinical Pharmacology
Changsha, Hunan, China, 410005
Sponsors and Collaborators
Central South University

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Responsible Party: Yijing He, Associate Professor, Central South University
ClinicalTrials.gov Identifier: NCT03245554     History of Changes
Other Study ID Numbers: 2017 PROP/CSU/GC
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yijing He, Central South University:
Gastrointestinal Cancer
Propranolol

Additional relevant MeSH terms:
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Propranolol
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents