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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin C+ mEHT+ supportive care | Experimental | 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. |
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| Supportive care | Placebo Comparator | Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin C | Drug | 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. |
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in Health Related Quality of Life (EORTC QLQ-C30) |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Junwen Ou, PhD | Clifford Hospital, Guangzhou, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clifford Hospital | Guangzhou | 511495 | China |
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| Modulated Electro-Hyperthermia (mEHT) | Device | 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. |
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| Supportive care | Other | Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc. |
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| basal,1,2,3,6,12 months follow up |
| Progression free Survival | CT assessment every 2 months |
| Overall Survival | every month follow up |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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