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

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clifford Hospital, Guangzhou, China
• Treatments: Ascorbic Acid; Vitamins

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