- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02655913
Safety and Efficacy of Vitamin C Infusion in Combination With Local mEHT to Treat Non Small Cell Lung Cancer (VCONSCLC)
November 29, 2018 updated by: Clifford Hospital, Guangzhou, China
Phase I-II Study of Vitamin C Infusion in Combination With Local mEHT on Non Small Cell Lung Cancer Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangzhou, China, 511495
- Clifford Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: vitamin C+ mEHT+ supportive care
Patients will be allocated into 3 Vitamin C infusion dosage groups: 1g/kg.d,1.2g/kg.d,1.5g/kg.d;3 times a week for 8 weeks(25 infusions);concurrent with Modulated Electro-Hyperthermia (mEHT): 150W x 60 min/session,3 times a week for 8 weeks (25 sessions);together with supportive care. |
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.
Other Names:
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.
Other Names:
Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc.
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Placebo Comparator: Supportive care
Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc.
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Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: weekly for up to 8 weeks
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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.
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weekly for up to 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-Tumor Response
Time Frame: 12 weeks after start of treatment
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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.
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12 weeks after start of treatment
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Changes in Health Related Quality of Life (EORTC QLQ-C30)
Time Frame: basal,1,2,3,6,12 months follow up
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basal,1,2,3,6,12 months follow up
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Progression free Survival
Time Frame: CT assessment every 2 months
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CT assessment every 2 months
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Overall Survival
Time Frame: every month follow up
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every month follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Junwen Ou, PhD, Clifford Hospital, Guangzhou, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2015
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
January 7, 2016
First Submitted That Met QC Criteria
January 13, 2016
First Posted (Estimate)
January 14, 2016
Study Record Updates
Last Update Posted (Actual)
November 30, 2018
Last Update Submitted That Met QC Criteria
November 29, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Ascorbic Acid
Other Study ID Numbers
- CHVCONSCLC1842
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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