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

January 7, 2019 updated by: Clifford Hospital, Guangzhou, China

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Guangzhou, China, 511495
        • Recruiting
        • Clifford Hospital
        • Contact:
        • Principal Investigator:
          • Junwen Ou, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Vitamin C
Participants will receive intravenous vitamin C therapy at the indicated dose.
Other Names:
  • Sodium Ascorbate
Drug: Tyrosine kinase inhibitor
Participants will receive Tyrosine kinase inhibitor therapy in cycles: continuous treatment at the indicated dose.
Experimental: 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.)
Drug: Tyrosine kinase inhibitor
Participants will receive Tyrosine kinase inhibitor therapy in cycles: continuous treatment at the indicated dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: From the start date of treatment until the date of first documented progression or death, assessed up to 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From the start date of treatment until the date of death from any cause, assessed up to 2 years.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Health Related Quality of Life: European Organisation for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ)-C30
Time Frame: From the start date of treatment until the date of first documented progression or death, assessed up to 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clifford Hospital, Guangzhou, China

Investigators

  • Study Chair: Junwen Ou, PhD, Clifford Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

January 2, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 10, 2019

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/2018-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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