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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03799094
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Information provided by (Responsible Party):
Clifford Hospital, Guangzhou, China

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Vitamin C Drug: Tyrosine kinase inhibitor Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Outcomes of Intravenous Vitamin C Synergy With Tyrosine Kinase Inhibitor in Lung Adenocarcinoma Patients With Epidermal Growth Factor Receptor Mutations
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

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 Name: 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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03799094

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Contact: Junwen Ou, PhD 86-13556021810

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Clifford Hospital Recruiting
Guangzhou, China, 511495
Contact: Junwen Ou, PhD    86-13556021810   
Principal Investigator: Junwen Ou, PhD         
Sponsors and Collaborators
Clifford Hospital, Guangzhou, China
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Study Chair: Junwen Ou, PhD Clifford Hospital
  Study Documents (Full-Text)

Documents provided by Clifford Hospital, Guangzhou, China:
Informed Consent Form  [PDF] November 14, 2018

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Responsible Party: Clifford Hospital, Guangzhou, China Identifier: NCT03799094    
Other Study ID Numbers: 2/2018-19
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clifford Hospital, Guangzhou, China:
tyrosine kinase inhibitor
Vitamin C
non-small cell lung cancer
progression-free survival
overall survival
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Ascorbic Acid
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents