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

NCT03245554 | Unknown Early Phase 1 DMC

• 1 other identifier: 2017 PROP/CSU/GC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastrointestinal Cancer

Keywords

Gastrointestinal Cancer; Propranolol

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

placebo and propranolol

EXPERIMENTAL

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

Drug: Propranolol

Interventions

Propranolol 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.

Also known as: placebo

placebo and propranolol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Institute of Clinical Pharmacology

Changsha, Hunan, 410005, China

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Yijing He

CONTACT

+86-1587481262; yijinghe@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 10, 2017
• Study Start: May 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 9, 2018

Record last verified: 2018-04

Locations

CN (1)