Status:
UNKNOWN
Vitamin C and Tyrosine Kinase Inhibitor in Lung Cancer Patients With Epidermal Growth Factor Receptor Mutations
Lead Sponsor:
Clifford Hospital, Guangzhou, China
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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) mutati...
Detailed Description
The effects of vitamin C in combination with tyrosine kinase inhibitor on tumor size, tumor markers, inflammatory factor levels, quality of life, duration of resistance, progression-free survival, and...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03799094
Start Date
December 5 2018
End Date
December 31 2022
Last Update
January 10 2019
Active Locations (1)
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1
Clifford Hospital
Guangzhou, China, 511495