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

NCT03799094 | Unknown Phase 1

• 1 other identifier: 2/2018-19
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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) mutations, and can benefit NSCLC patients.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

tyrosine kinase inhibitor; Vitamin C; non-small cell lung cancer; progression-free survival; overall survival

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall survival

  From the start date of treatment until the date of death from any cause, assessed up to 2 years.

Other Outcomes (1)

• Changes in Health Related Quality of Life: European Organisation for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ)-C30

  From the start date of treatment until the date of first documented progression or death, assessed up to 2 years

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Drug: Vitamin C; Drug: Tyrosine kinase inhibitor

Control group

EXPERIMENTAL

75 patients received tyrosine kinase inhibitor daily. (dose: Osimertinib 80 mg/d, or Tarceva 150 mg/d, or Iressa 0.25 g/d.)

Drug: Tyrosine kinase inhibitor

Interventions

Vitamin C DRUG

Participants will receive intravenous vitamin C therapy at the indicated dose.

Also known as: Sodium Ascorbate

Experimental group

Tyrosine kinase inhibitor DRUG

Participants will receive Tyrosine kinase inhibitor therapy in cycles: continuous treatment at the indicated dose.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Clifford Hospital, Guangzhou, China: lead

Study Sites (1)

Clifford Hospital

Guangzhou, 511495, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Ascorbic Acid; Tyrosine Kinase Inhibitors

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Junwen Ou, PhD

  Clifford Hospital

  STUDY CHAIR

Central Study Contacts

Junwen Ou, PhD

CONTACT

86-13556021810; oujunwen66@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 10, 2019
• Study Start: December 5, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2022
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

CN (1)