Phase I-II Study of Vitamin C Infusion in Combination With Local mEHT on Non Small Cell Lung Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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
研究组 & 干预措施
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.
干预措施: vitamin C (Drug)
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.
干预措施: Modulated Electro-Hyperthermia (mEHT) (Device)
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.
干预措施: Supportive care (Other)
Supportive care
Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc.
干预措施: Supportive care (Other)
结局指标
主要结局
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
时间窗: 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.
次要结局
- Overall Survival(every month follow up)
- Progression free Survival(CT assessment every 2 months)
- Anti-Tumor Response(12 weeks after start of treatment)
- Changes in Health Related Quality of Life (EORTC QLQ-C30)(basal,1,2,3,6,12 months follow up)