Clinical trial · Interventional
Safety and Efficacy of Vitamin C Infusion in Combination With Local mEHT to Treat Non Small Cell Lung Cancer
Phase I-II Study of Vitamin C Infusion in Combination With Local mEHT on Non Small Cell Lung Cancer Patients
NCT02655913CI-TRIAL-00035987VCONSCLCcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Recurrent Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIA Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modulated Electro-Hyperthermia (mEHT) | Device | — | UNRESOLVED |
| Supportive care | Other | — | UNRESOLVED |
| vitamin C | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- vitamin C+ mEHT+ supportive care
- description
- 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.
- interventionNames
- Drug: vitamin C
- Device: Modulated Electro-Hyperthermia (mEHT)
- Other: Supportive care
- type
- PLACEBO_COMPARATOR
- label
- Supportive care
- description
- Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc.
- interventionNames
- Other: Supportive care
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion criteria: * 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 * 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 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
References
Publications (0)
Data not yet available
No reference posted for this study.