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Carcinoma, Non-Small-Cell LungPhase 1/2VCONSCLCNCT02655913

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

A Phase 1/2 study testing vitamin C, Modulated Electro-Hyperthermia (mEHT) and Supportive care in people with Carcinoma, Non-Small-Cell Lung and Stage IIIA Non-small Cell Lung Cancer, run by Clifford Hospital, Guangzhou, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
vitamin C, Modulated Electro-Hyperthermia (mEHT) and Supportive care
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
97 participants
Where
1 siteChina
Study dates
Dec 2015to Aug 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Clifford Hospital

    Guangzhou, 511495

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
vitamin C, Modulated Electro-Hyperthermia (mEHT), Supportive care
Keywords
Sodium ascorbate, Non-Small-Cell Lung cancer, Oncothermia, Immune function, Life quality, Tumor marker, Survival time
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vitamin CDrug

    Also called Sodium Ascorbate

    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.

  • Modulated Electro-Hyperthermia (mEHT)Device

    Also called Oncothermia

    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.

  • Supportive careOther

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

Study groups in NCT02655913
Study groupRoleWhat they receive
vitamin C+ mEHT+ supportive careExperimentalPatients 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.
Receives: Drug: vitamin C; Device: Modulated Electro-Hyperthermia (mEHT); Other: Supportive care
Supportive carePlacebo comparatorSupportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc.
Receives: Other: Supportive care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: weekly for up to 8 weeks

Secondary outcomes (4)

  1. 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.

    Measured: 12 weeks after start of treatment

  2. Changes in Health Related Quality of Life (EORTC QLQ-C30)

    Measured: basal,1,2,3,6,12 months follow up

  3. Progression free Survival

    Measured: CT assessment every 2 months

  4. Overall Survival

    Measured: every month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionAug 2017
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02655913
Sponsor's protocol ID
CHVCONSCLC1842
Acronym
VCONSCLC
Status last verified
Nov 2018
First submitted
7 Jan 2016
Last updated
30 Nov 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing vitamin C, Modulated Electro-Hyperthermia (mEHT) and Supportive care in people with Carcinoma, Non-Small-Cell Lung and Stage IIIA Non-small Cell Lung Cancer, run by Clifford Hospital, Guangzhou, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02655913.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.

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