Clinical trial NCT02655913: Safety and Efficacy of Vitamin C Infusion in Combination With Local mEHT to Treat Non Small Cell Lung Cancer
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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: Clifford Hospital, Guangzhou, China
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: weekly for up to 8 weeks
Secondary outcomes:
measure: Anti-Tumor Response
timeFrame: 12 weeks after start of treatment
measure: Changes in Health Related Quality of Life (EORTC QLQ-C30)
timeFrame: basal,1,2,3,6,12 months follow up
measure: Progression free Survival
timeFrame: CT assessment every 2 months
measure: Overall Survival
timeFrame: every month follow up
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Clifford Hospital
Study officials:
affiliation: Clifford Hospital, Guangzhou, China
name: Junwen Ou, PhD
role: PRINCIPAL_INVESTIGATOR
References: