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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Clinical Outcomes of Intravenous Vitamin C Synergy With Tyrosine Kinase Inhibitor in Lung Adenocarcinoma Patients With Epidermal Growth Factor Receptor Mutations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03799094
• Other study ID #: 2/2018-19
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 5, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2019
• Source: Clifford Hospital, Guangzhou, China
• Contact: Junwen Ou, PhD
• Phone: 86-13556021810
• Email: oujunwen66[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 overall survival time were evaluated.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Clifford Hospital	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Clifford Hospital, Guangzhou, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Health Related Quality of Life: European Organisation for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ)-C30	Using QLQ-C30: Function subscales, (include physical, role, emotional, cognitive, social, global) (averaged, 0-100, higher value represent a better outcome); Symptoms subscales (include fatigue, nausea, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea) (averaged, 0-100, lower value represent a better outcome). Given at basal, 1, 2, 3, 6, 12 months.	From the start date of treatment until the date of first documented progression or death, assessed up to 2 years
Primary	Progression free survival	From the start of treatment until the patient has tumor progression or death	From the start date of treatment until the date of first documented progression or death, assessed up to 2 years
Secondary	Overall survival	The length of time from the start of treatment for a disease until death	From the start date of treatment until the date of death from any cause, assessed up to 2 years.