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

Phase 1

Completed

• 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
• Interventions: Drug: vitamin C; Device: Modulated Electro-Hyperthermia (mEHT); Other: Supportive care

• Registration Number: NCT02655913
• Lead Sponsor: Clifford Hospital, Guangzhou, China

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-14
• Primary Completion: 2017-08
• Study Completion: 2018-08
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-29
• Last Update Posted: 2018-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin C+ mEHT+ supportive care	Modulated Electro-Hyperthermia (mEHT)	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.
vitamin C+ mEHT+ supportive care	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.
Supportive care	Supportive care	Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc.
vitamin C+ mEHT+ supportive care	vitamin C	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.

Primary Outcome Measures

Name	Time	Method
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	weekly for up to 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Progression free Survival	CT assessment every 2 months
Overall Survival	every month follow up
Anti-Tumor Response	12 weeks after start of treatment	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.
Changes in Health Related Quality of Life (EORTC QLQ-C30)	basal,1,2,3,6,12 months follow up

Trial Locations

Locations (1)

Clifford Hospital; 🇨🇳 Guangzhou, China