non small cell lung cancer
Conditions
Interventions
treatment group:vitamin C infusion
treatment group:Electro-Hyperthermia
treatment group:Lifestyle counseling
control group:Lifestyle counseling
Sponsors
CLIFFORD HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Primary non small cell lung cancer (stage 3 and 4); 3. Subjects must have had their last therapy at least four weeks prior to entry to this study; 4. The patient must be willing and able to sign the informed consent prior to the start of the trial; 5. Candidates are not currently receiving cancer therapy (chemotherapy, molecular targeted drug therapy, and radiation therapy); 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2; 7. Willingness to comply with the weekly phone calls between office visits; 8. Patients must be able to take food orally or have peg tube for feeding; 9. Life expectancy of at least 6 months.
Exclusion criteria
Exclusion criteria: 1. Lung metastasis/not primary non small cell lung cancer; 2. Glucose-6-phosphate dehydrogenase deficiency (G6PD); 3. Vitamin C allergy; 4. Impossibility to place the patient into the mEHT machine; 5. Metallic implants or replacements in the treatment area; 6. Electronic implanted devices anywhere; 7. Missing or damaged heat-sense nerves or other field-sensitive issues in the treatment area; 8. 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; 9. Renal insufficiency as evidenced by serum creatinine of >=1.3mg/dl or evidence of oxalosis by urinalysis; 10. Chronic hemodialysis; 11. Iron overload (a ferritin > 500 ng/ml); 12. Wilson's disease; 13. 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*upper limit of normal; 14. Very low white blood cell count (< 1.5*10^9/L), agranulocytosis (< 0.5*10^9/L) or severe anemia; 15. Pregnant or lactating female; 16. Current tobacco use; 17. Evidence of significant psychiatric disorder by history or examination that would prevent completion of the study or preclude informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of vitamin C infusion in combination with oncothermia on NSCLC patients; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-Tumor Response;Levels of CD4+,CD8+;Biomarkers of inflammation;Health Related Quality of Life (EORTC QLQ-C30);Survival time; | — |
Countries
China
Contacts
Public ContactOu Junwen
Outcome results
None listed