Vitamin C and Tyrosine Kinase Inhibitor in Lung Cancer Patients With Epidermal Growth Factor Receptor Mutations
NCT ID: NCT03799094
Last Updated: 2019-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
150 participants
INTERVENTIONAL
2018-12-05
2022-12-31
Brief Summary
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Detailed Description
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This trial is a low risk treatment, and has developed the appropriate safety measures and contingency plans to ensure patients' safety in the whole process.
Patients will be followed up after the end of the trial, and follow-up observations will be performed every month during the first year. Followed every 3 months in the second year for 3 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental group
75 patients received a weekly intravenous Vitamin C injection (dose: 30 g / time, once a week, treatment termination when the disease progress is confirmed) in combination with daily taking tyrosine kinase inhibitor.
Vitamin C
Participants will receive intravenous vitamin C therapy at the indicated dose.
Tyrosine kinase inhibitor
Participants will receive Tyrosine kinase inhibitor therapy in cycles: continuous treatment at the indicated dose.
Control group
75 patients received tyrosine kinase inhibitor daily. (dose: Osimertinib 80 mg/d, or Tarceva 150 mg/d, or Iressa 0.25 g/d.)
Tyrosine kinase inhibitor
Participants will receive Tyrosine kinase inhibitor therapy in cycles: continuous treatment at the indicated dose.
Interventions
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Vitamin C
Participants will receive intravenous vitamin C therapy at the indicated dose.
Tyrosine kinase inhibitor
Participants will receive Tyrosine kinase inhibitor therapy in cycles: continuous treatment at the indicated dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Clifford Hospital, Guangzhou, China
OTHER
Responsible Party
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Principal Investigators
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Junwen Ou, PhD
Role: STUDY_CHAIR
Clifford Hospital
Locations
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Clifford Hospital
Guangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2/2018-19
Identifier Type: -
Identifier Source: org_study_id
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