Safety and Efficacy of Vitamin C Infusion in Combination With Local mEHT to Treat Non Small Cell Lung Cancer
Condition: 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
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): vitamin C; Modulated Electro-Hyperthermia (mEHT); Supportive care
Intervention type(s): Drug; Device; Other
Intervention description(s): 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.; 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.; Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc.
Other intervention name(s): Sodium Ascorbate; Oncothermia
Intervention MeSH terms: Ascorbic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sodium ascorbate; Non-Small-Cell Lung cancer; Oncothermia; Immune function; Life quality; Tumor marker; Survival time