Vitamin C and Tyrosine Kinase Inhibitor in Lung Cancer Patients With Epidermal Growth Factor Receptor Mutations

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This trial was to explore whether intravenous vitamin C can prolong resistance time of Tyrosine Kinase Inhibitor(TKI) on lung adenocarcinoma patients with Epidermal Growth Factor Receptor(EGFR) mutations, and can benefit NSCLC patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clifford Hospital, Guangzhou, China
• Treatments: Ascorbic Acid; Mitogens; Vitamins

Criteria

Inclusion Criteria:

• Primary non-small cell lung cancer (adenocarcinoma) with EGFR mutations on exons 19 and 21.

• 18 years old to 75 years old.

• During the trial, patients were prescribed TKI drugs(received initial treatment within 2 months, or change medication within 2 months) and did not receive chemotherapy or radiotherapy at the same time.

• Eastern Cooperative Oncology Group (ECOG) performance status are 0 to 2.

• Expected survival over 3 months.

• Household registration is Guangdong Province.

Exclusion Criteria:

• Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), and uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.

• Glucose-6-phosphate dehydrogenase deficiency (G6PD) (a relative contraindication).

• Patients who are allergic to vitamin C.

• Patients with HIV and other infectious diseases.

• Patients who are taking anticoagulants and have coagulopathy;

• Combine dysfunction of important organs such as heart, lung, liver and kidney;

• Patients with impaired renal function (serum creatinine content > 1.2 mg/dL)

• Compromised liver function with evidence of Serum total bilirubin content, Serum alanine aminotransferase(ALT) and aspartate transaminase(AST)> 2 times normal reference value.

• Pregnant or lactating female.

• Smoking and alcohol abuse patients;

• Anti-infective treatment is required for systemic or localized serious infections;

• Patients with hyperuricacidemia (normal: 91-456 μmol / 24h (8-40mg / 24h));

• Wilson's disease.

• Evidence of significant psychiatric disorder by history or examination that would prevent completion of the study or preclude informed consent.

• Any condition that impairs the patients' ability to swallow, which impairs drug absorption or drug kinetic parameters, including any kind of gastrointestinal resection or surgery;

• History of surgery of visceral organs within 6 weeks before the study.