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Safety and Efficacy of Vitamin C Infusion in Combination With Local mEHT to Treat Non Small Cell Lung Cancer (VCONSCLC)

Primary Purpose

Carcinoma, Non-Small-Cell Lung, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
vitamin C
Modulated Electro-Hyperthermia (mEHT)
Supportive care
Sponsored by
Clifford Hospital, Guangzhou, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Sodium ascorbate, Non-Small-Cell Lung cancer, Oncothermia, Immune function, Life quality, Tumor marker, Survival time

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • 18 years old to 70 years
  • Primary non small cell lung cancer (stage 3 and 4)
  • Subjects must have had their last cancer therapy at least four weeks prior to entry to this study
  • The patient must be willing and able to sign the informed consent prior to the start of the trial
  • Candidates are not currently receiving cancer therapy (chemotherapy, molecular targeted drug therapy, and radiation therapy)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Willingness to comply with the weekly phone calls between office visits
  • Patients must be able to take food orally or have peg tube for feeding
  • Life expectancy of at least 6 months

Exclusion Criteria:

  • Lung metastasis/not primary non small cell lung cancer
  • Glucose-6-phosphate dehydrogenase deficiency (G6PD)
  • Vitamin C allergy
  • Impossibility to place the patient into the mEHT machine
  • Metallic implants or replacements in the treatment area
  • Electronic implanted devices anywhere
  • Missing or damaged heat-sense nerves or other field-sensitive issues in the treatment area
  • 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
  • Renal insufficiency as evidenced by serum creatinine of ≥ 1.3mg/dl or evidence of oxalosis by urinalysis
  • Chronic hemodialysis
  • Iron overload (a ferritin > 500 ng/ml)
  • Wilson's disease
  • Compromised liver function with evidence of complete biliary obstruction or have a serum bilirubin of 2.0 or liver function tests (AST > 63, ALT > 95) exceeding 1.5 x the upper limit of normal
  • Very low white blood cell count (< 1.5 x 10(9)/L), agranulocytosis (< 0.5 x 10(9)/L) or severe anemia
  • Pregnant or lactating female
  • Current tobacco use
  • Evidence of significant psychiatric disorder by history or examination that would prevent completion of the study or preclude informed consent

Sites / Locations

  • Clifford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

vitamin C+ mEHT+ supportive care

Supportive care

Arm Description

Patients will be allocated into 3 Vitamin C infusion dosage groups: 1g/kg.d,1.2g/kg.d,1.5g/kg.d;3 times a week for 8 weeks(25 infusions);concurrent with Modulated Electro-Hyperthermia (mEHT): 150W x 60 min/session,3 times a week for 8 weeks (25 sessions);together with supportive care.

Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc.

Outcomes

Primary Outcome Measures

Safety and tolerability of vitamin C infusion（1g/kg.d, 1.2g/kg.d,1.5g/kg.d） in combination with oncothermia on NSCLC patients
Adverse events, whether volunteered by the study subject, discovered by the investigators during questioning, or detected by physical examination, laboratory tests, or other means will be collected and recorded at each visit. Events will be recorded from the time the consent is signed until 4 weeks after the study protocol is discontinued.

Secondary Outcome Measures

Anti-Tumor Response
Tumor markers such as CEA,CYFRA21-1,CA153,SCC will be evaluated at baseline and one month after completion of treatment. Enhanced CT scan will be performed at baseline and one months after completion of treatment to measure the size of the tumor.
Changes in Health Related Quality of Life (EORTC QLQ-C30)
Progression free Survival
Overall Survival

Full Information

First Posted
January 7, 2016
Last Updated
November 29, 2018
Sponsor
Clifford Hospital, Guangzhou, China
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1. Study Identification

Unique Protocol Identification Number
NCT02655913
Brief Title
Safety and Efficacy of Vitamin C Infusion in Combination With Local mEHT to Treat Non Small Cell Lung Cancer
Acronym
VCONSCLC
Official Title
Phase I-II Study of Vitamin C Infusion in Combination With Local mEHT on Non Small Cell Lung Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clifford Hospital, Guangzhou, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial studies efficacy and safety of combination of vitamin C infusion with modulated electro-hyperthermia (mEHT) in treatment of non small cell lung cancer patients.Phase I of this clinical study is to find the tolerable dose and best schedule of the combination of vitamin C infusion and mEHT that can be given to patients with NSCLC. Phase II of this study is to learn if the combination of vitamin C infusion and mEHT can help to control NSCLC and improve quality of life.
Detailed Description
Phase I and Phase II clinical trial indicated large dose of vitC infusion is safe and can reduce toxic side effects from chemo drugs when it was used synergy with chemotherapy. The new technology of modulated electro-hyperthermia (mEHT),trade name: oncothermia has been proven efficacy in lung cancer with minimal side effects.The investigators have accumulated some successful cases in the treatment of primary lung cancer by using vitamin C infusion in combination with oncothermia. One diagnosed with squamous cell lung cancer patient survive beyond 5 years only receiving intravenous vitamin C+ mEHT. Based on this, it is necessary to conduct an in-depth study to explore the best treatment protocol for NSCLC patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer
Keywords
Sodium ascorbate, Non-Small-Cell Lung cancer, Oncothermia, Immune function, Life quality, Tumor marker, Survival time

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin C+ mEHT+ supportive care
Arm Type
Experimental
Arm Description
Patients will be allocated into 3 Vitamin C infusion dosage groups: 1g/kg.d,1.2g/kg.d,1.5g/kg.d;3 times a week for 8 weeks(25 infusions);concurrent with Modulated Electro-Hyperthermia (mEHT): 150W x 60 min/session,3 times a week for 8 weeks (25 sessions);together with supportive care.
Arm Title
Supportive care
Arm Type
Placebo Comparator
Arm Description
Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc.
Intervention Type
Drug
Intervention Name(s)
vitamin C
Other Intervention Name(s)
Sodium Ascorbate
Intervention Description
Vitamin C infusion, as an alternative anticancer therapy, has been used for many years. In the last 10 years, an increasing number of studies have indicated that VitC in pharmacological concentration can selectively kill cancer cells. Phase I clinical trial showed that VitC(1.5g/kg, 90-120mins, 3 times a week) infusion is safe without significant adverse reactions. A phase II clinical trial indicated that large dose of vitC infusion can reduce toxic side effects from chemo drugs when it was used synergy with chemotherapy.
Intervention Type
Device
Intervention Name(s)
Modulated Electro-Hyperthermia (mEHT)
Other Intervention Name(s)
Oncothermia
Intervention Description
MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.
Intervention Type
Other
Intervention Name(s)
Supportive care
Intervention Description
Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc.
Primary Outcome Measure Information:
Title
Safety and tolerability of vitamin C infusion（1g/kg.d, 1.2g/kg.d,1.5g/kg.d） in combination with oncothermia on NSCLC patients
Description
Adverse events, whether volunteered by the study subject, discovered by the investigators during questioning, or detected by physical examination, laboratory tests, or other means will be collected and recorded at each visit. Events will be recorded from the time the consent is signed until 4 weeks after the study protocol is discontinued.
Time Frame
weekly for up to 8 weeks
Secondary Outcome Measure Information:
Title
Anti-Tumor Response
Description
Tumor markers such as CEA,CYFRA21-1,CA153,SCC will be evaluated at baseline and one month after completion of treatment. Enhanced CT scan will be performed at baseline and one months after completion of treatment to measure the size of the tumor.
Time Frame
12 weeks after start of treatment
Title
Changes in Health Related Quality of Life (EORTC QLQ-C30)
Time Frame
basal,1,2,3,6,12 months follow up
Title
Progression free Survival
Time Frame
CT assessment every 2 months
Title
Overall Survival
Time Frame
every month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 18 years old to 70 years Primary non small cell lung cancer (stage 3 and 4) Subjects must have had their last cancer therapy at least four weeks prior to entry to this study The patient must be willing and able to sign the informed consent prior to the start of the trial Candidates are not currently receiving cancer therapy (chemotherapy, molecular targeted drug therapy, and radiation therapy) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Willingness to comply with the weekly phone calls between office visits Patients must be able to take food orally or have peg tube for feeding Life expectancy of at least 6 months Exclusion Criteria: Lung metastasis/not primary non small cell lung cancer Glucose-6-phosphate dehydrogenase deficiency (G6PD) Vitamin C allergy Impossibility to place the patient into the mEHT machine Metallic implants or replacements in the treatment area Electronic implanted devices anywhere Missing or damaged heat-sense nerves or other field-sensitive issues in the treatment area 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 Renal insufficiency as evidenced by serum creatinine of ≥ 1.3mg/dl or evidence of oxalosis by urinalysis Chronic hemodialysis Iron overload (a ferritin > 500 ng/ml) Wilson's disease Compromised liver function with evidence of complete biliary obstruction or have a serum bilirubin of 2.0 or liver function tests (AST > 63, ALT > 95) exceeding 1.5 x the upper limit of normal Very low white blood cell count (< 1.5 x 10(9)/L), agranulocytosis (< 0.5 x 10(9)/L) or severe anemia Pregnant or lactating female Current tobacco use Evidence of significant psychiatric disorder by history or examination that would prevent completion of the study or preclude informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junwen Ou, PhD
Organizational Affiliation
Clifford Hospital, Guangzhou, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clifford Hospital
City
Guangzhou
ZIP/Postal Code
511495
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Safety and Efficacy of Vitamin C Infusion in Combination With Local mEHT to Treat Non Small Cell Lung Cancer

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