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

NCT02655913 | Completed Phase 1 DMC

• 1 other identifier: CHVCONSCLC1842
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

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

Keywords

Sodium ascorbate; Non-Small-Cell Lung cancer; Oncothermia; Immune function; Life quality; Tumor marker; Survival time

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Progression free Survival

  CT assessment every 2 months

• Overall Survival

  every month follow up

Study Arms (2)

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.

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

Supportive care

PLACEBO COMPARATOR

Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc.

Other: Supportive care

Interventions

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.

Also known as: Sodium Ascorbate

vitamin C+ mEHT+ supportive care

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.

Also known as: Oncothermia

vitamin C+ mEHT+ supportive care

Supportive care OTHER

Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc.

Supportive care; vitamin C+ mEHT+ supportive care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clifford Hospital, Guangzhou, China: lead

Study Sites (1)

Clifford Hospital

Guangzhou, 511495, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Ascorbic Acid; Palliative Care

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Junwen Ou, PhD

  Clifford Hospital, Guangzhou, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 14, 2016
• Study Start: December 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2018
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

CN (1)