Prevention of Cancer Development and Progression

NCT03940053 | Unknown Phase 3

• 1 other identifier: APT-001
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of arginine in preventing cancer development

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence

  the percentage of patients with cancer from start of treatment to follow-up date of last participant cancers Incidence

  60 months

Secondary Outcomes (2)

• tumor markers

  60 months

• Chinese Quality of Life Questionnaire - EORTC QLQ-C30 score

  60 months

Study Arms (2)

Observation

NO INTERVENTION

Subjects only accept the routine treatment for underlying diseases.

Intervention

EXPERIMENTAL

Based on the routine treatment for underlying diseases, subjects were administrated by arginine.

Drug: Arginine hydrochloride

Interventions

Arginine hydrochloride DRUG

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

Intervention

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Zujiang YU: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Arginine

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The director of infectious diseases department

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 7, 2019
• Study Start: May 10, 2019
• Primary Completion: August 10, 2024
• Study Completion: May 10, 2025
• Last Updated: May 7, 2019

Record last verified: 2019-05