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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Prevention of Cancer Development and Progression

  • Clinicaltrials.gov identifier

    NCT03940053

  • Recruitment Status

    Not yet recruiting

  • First Posted

    May 7, 2019

  • Last update posted

    May 7, 2019

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:Cancer
  • Intervention/Treatment: Drug: Arginine hydrochloride
  • Phase: 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

  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: August 2024
  • Estimated Study Completion Date: May 2025

Arms and interventions

Arm Intervention/treatment
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

  • Ages Eligible for Study: 40 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 AST140 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

Contacts

Locations

Sponsors and Collaborators

Zujiang YU

More Information

  • Responsible Party: Zujiang YU
  • ClinicalTrials.gov Identifier: NCT03940053 History of Changes
  • Other Study ID Numbers: APT-001
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 7, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No