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出境医 / 临床实验 / Prevention of Cancer Development and Progression

Prevention of Cancer Development and Progression

Study Description
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of arginine in preventing cancer development

Condition or disease Intervention/treatment Phase
Cancer Drug: Arginine hydrochloride Phase 3

Detailed Description:
Cancer is considered to be the leading cause of death among non-infectious diseases and the most important obstacle to increase life expectancy for every country in the 21st century. However, even if various interventions such as embolization chemotherapy, systemic chemotherapy, radiofrequency ablation, and targeted therapy are widely used in clinical practice, the improvement of patients' survival is still limited. Our previous study found that arginine hydrochloride could significantly promote the apoptosis of liver cancer cells, and inhibit the progression of HCC by prompting the urea cycle. Therefore, our research group has carried out this study to evaluate the efficacy of arginine in preventing cancers.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Efficacy of Arginine in Preventing Cancers. A Single Center, Open, Prospective Study
Estimated Study Start Date : May 10, 2019
Estimated Primary Completion Date : August 10, 2024
Estimated Study Completion Date : May 10, 2025
Arms and Interventions
Arm Intervention/treatment
No Intervention: Observation
Subjects only accept the routine treatment for underlying diseases.
Experimental: Intervention
Based on the routine treatment for underlying diseases, subjects were administrated by arginine.
 Drug: Arginine hydrochloride
Arginine hydrochloride injection 5g/dose; 40g/d; ivgtt; sustained medication for 24 days; drug withdrawal for 4 days. Treatment is continued until the levels of tumor marker dropped to normal
Outcome Measures
Primary Outcome Measures :
  1. Incidence [ Time Frame: 60 months ]
    the percentage of patients with cancer from start of treatment to follow-up date of last participant cancers Incidence


Secondary Outcome Measures :
  1. tumor markers [ Time Frame: 60 months ]
    the levels of tumor markers in every check point

  2. Chinese Quality of Life Questionnaire - EORTC QLQ-C30 score [ Time Frame: 60 months ]
    The overall enjoyment of life


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Ages 40-75 years 2. 2 ULN of tumor markers (CEA, AFP, ca-125, ca19-9, NSE, HCG and cyfra21-1) 3. No space-occupying lesions were found by the current imaging examination 4. The major organ function is normal that is meeting the following standards: Blood routine examination: (No blood transfusion, no G-CSF and no medication were corrected within 14 days before screening) a.HB≥80g/L； b.ANC≥1.5×109/L；c.PLT≥50×109/L; Biochemical examination: (ALB was not transfused within 14 days before screening) a. ALB ≥29 g/L； b.ALT and AST<5ULN；c. TBIL ≤3ULN；d.creatinine ≤1.5ULN( albumin and bilirubin, two indicators of Child-Pugh liver function class, can only have one for 2 points) 5. For women of childbearing age, the results of serum/urine pregnancy tests must be negative within 7 days before initiation of treatment. All men and women who participate in the study have to take reliable contraceptive measures within the trial and eight weeks after the trial is completed 6. volunteers must signed informed consent.

Exclusion Criteria:

  • 1. patients suffering from any malignant tumors in the past (within 5 years) or at the same time; excluding cured basal cell carcinoma and carcinoma in situs of cervix 2. Patients who are undergoing transplantation or have a history of organ transplantation 3. Patients with an allergic history of arginine hydrochloride 4. The blood pressure cannot be reduced to the normal range by the antihypertensive drug treatment in patients with hypertension(systolic pressure>140 mmHg, diastolic pressure>90 mmHg) 5. Patients with myocardial ischemia or myocardial infarction over grade II or a poorly controlled arrhythmia (including QTc interval: men ≥450 ms; women ≥470 ms) 6.Cardiac functional insufficiency of grade III to IV according to NYHA standard; echocardiography: LVEF<50% 7. Patients with severe organ damage and less than 3 years expected survival time 8. Pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptives 9. Patients with mental sickness or the history of psychotropic drug abuse 10. Patients with severe infection (unable to control the infection effectively) 11. The researchers believe that any other factors unsuitable for entering into the study.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE May 5, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date May 7, 2019
Estimated Study Start Date  ICMJE May 10, 2019
Estimated Primary Completion Date August 10, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2019) 		Incidence [ Time Frame: 60 months ]
the percentage of patients with cancer from start of treatment to follow-up date of last participant cancers Incidence
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2019)
  • tumor markers [ Time Frame: 60 months ]
    the levels of tumor markers in every check point
  • Chinese Quality of Life Questionnaire - EORTC QLQ-C30 score [ Time Frame: 60 months ]
    The overall enjoyment of life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Cancer Development and Progression
Official Title  ICMJE The Efficacy of Arginine in Preventing Cancers. A Single Center, Open, Prospective Study
Brief Summary The purpose of this study is to evaluate the efficacy and safety of arginine in preventing cancer development
Detailed Description Cancer is considered to be the leading cause of death among non-infectious diseases and the most important obstacle to increase life expectancy for every country in the 21st century. However, even if various interventions such as embolization chemotherapy, systemic chemotherapy, radiofrequency ablation, and targeted therapy are widely used in clinical practice, the improvement of patients' survival is still limited. Our previous study found that arginine hydrochloride could significantly promote the apoptosis of liver cancer cells, and inhibit the progression of HCC by prompting the urea cycle. Therefore, our research group has carried out this study to evaluate the efficacy of arginine in preventing cancers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cancer
Intervention  ICMJE Drug: Arginine hydrochloride
Arginine hydrochloride injection 5g/dose; 40g/d; ivgtt; sustained medication for 24 days; drug withdrawal for 4 days. Treatment is continued until the levels of tumor marker dropped to normal
Study Arms  ICMJE
  • No Intervention: Observation
    Subjects only accept the routine treatment for underlying diseases.
  • Experimental: Intervention
    Based on the routine treatment for underlying diseases, subjects were administrated by arginine.
    Intervention: Drug: Arginine hydrochloride
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: May 5, 2019) 		300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 10, 2025
Estimated Primary Completion Date August 10, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Ages 40-75 years 2. 2 ULN of tumor markers (CEA, AFP, ca-125, ca19-9, NSE, HCG and cyfra21-1) 3. No space-occupying lesions were found by the current imaging examination 4. The major organ function is normal that is meeting the following standards: Blood routine examination: (No blood transfusion, no G-CSF and no medication were corrected within 14 days before screening) a.HB≥80g/L； b.ANC≥1.5×109/L；c.PLT≥50×109/L; Biochemical examination: (ALB was not transfused within 14 days before screening) a. ALB ≥29 g/L； b.ALT and AST<5ULN；c. TBIL ≤3ULN；d.creatinine ≤1.5ULN( albumin and bilirubin, two indicators of Child-Pugh liver function class, can only have one for 2 points) 5. For women of childbearing age, the results of serum/urine pregnancy tests must be negative within 7 days before initiation of treatment. All men and women who participate in the study have to take reliable contraceptive measures within the trial and eight weeks after the trial is completed 6. volunteers must signed informed consent.

Exclusion Criteria:

  • 1. patients suffering from any malignant tumors in the past (within 5 years) or at the same time; excluding cured basal cell carcinoma and carcinoma in situs of cervix 2. Patients who are undergoing transplantation or have a history of organ transplantation 3. Patients with an allergic history of arginine hydrochloride 4. The blood pressure cannot be reduced to the normal range by the antihypertensive drug treatment in patients with hypertension(systolic pressure>140 mmHg, diastolic pressure>90 mmHg) 5. Patients with myocardial ischemia or myocardial infarction over grade II or a poorly controlled arrhythmia (including QTc interval: men ≥450 ms; women ≥470 ms) 6.Cardiac functional insufficiency of grade III to IV according to NYHA standard; echocardiography: LVEF<50% 7. Patients with severe organ damage and less than 3 years expected survival time 8. Pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptives 9. Patients with mental sickness or the history of psychotropic drug abuse 10. Patients with severe infection (unable to control the infection effectively) 11. The researchers believe that any other factors unsuitable for entering into the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03940053
Other Study ID Numbers  ICMJE APT-001
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Zujiang YU, The First Affiliated Hospital of Zhengzhou University
Study Sponsor  ICMJE Zujiang YU
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The First Affiliated Hospital of Zhengzhou University
Verification Date May 2019

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

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