Carcinoma, Non-Small-Cell Lung Clinical Trial
— VCONSCLCOfficial title:
Phase I-II Study of Vitamin C Infusion in Combination With Local mEHT on Non Small Cell Lung Cancer Patients
Verified date | November 2018 |
Source | Clifford Hospital, Guangzhou, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 97 |
Est. completion date | August 2018 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Clifford Hospital | Guangzhou |
Lead Sponsor | Collaborator |
---|---|
Clifford Hospital, Guangzhou, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | weekly for up to 8 weeks | |
Secondary | Anti-Tumor Response | 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. | 12 weeks after start of treatment | |
Secondary | Changes in Health Related Quality of Life (EORTC QLQ-C30) | basal,1,2,3,6,12 months follow up | ||
Secondary | Progression free Survival | CT assessment every 2 months | ||
Secondary | Overall Survival | every month follow up |
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