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

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ClinicalTrials.gov Identifier: NCT02655913
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Clifford Hospital, Guangzhou, China

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.

Condition or disease Intervention/treatment Phase
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 Drug: vitamin C Device: Modulated Electro-Hyperthermia (mEHT) Other: Supportive care Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I-II Study of Vitamin C Infusion in Combination With Local mEHT on Non Small Cell Lung Cancer Patients
Actual Study Start Date : December 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
Experimental: vitamin C+ mEHT+ supportive care

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.

Drug: vitamin C
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.
Other Name: Sodium Ascorbate

Device: Modulated Electro-Hyperthermia (mEHT)
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.
Other Name: Oncothermia

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

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




Primary Outcome Measures :
  1. 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 [ Time Frame: weekly for up to 8 weeks ]
    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 :
  1. Anti-Tumor Response [ Time Frame: 12 weeks after start of treatment ]
    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.

  2. Changes in Health Related Quality of Life (EORTC QLQ-C30) [ Time Frame: basal,1,2,3,6,12 months follow up ]
  3. Progression free Survival [ Time Frame: CT assessment every 2 months ]
  4. Overall Survival [ Time Frame: every month follow up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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 ClinicalTrials.gov identifier (NCT number): NCT02655913


Locations
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China
Clifford Hospital
Guangzhou, China, 511495
Sponsors and Collaborators
Clifford Hospital, Guangzhou, China
Investigators
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Principal Investigator: Junwen Ou, PhD Clifford Hospital, Guangzhou, China
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Responsible Party: Clifford Hospital, Guangzhou, China
ClinicalTrials.gov Identifier: NCT02655913    
Other Study ID Numbers: CHVCONSCLC1842
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Clifford Hospital, Guangzhou, China:
Sodium ascorbate
Non-Small-Cell Lung cancer
Oncothermia
Immune function
Life quality
Tumor marker
Survival time
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Ascorbic Acid
Vitamins
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents