Clinical trial · Interventional
Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer
Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer: A Double Blind, Placebo Controlled, Phase II Randomized Controlled Trial
NCT05849129CI-TRIAL-00101585AIVAArecruitingPhase 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 is a two arm RCT evaluating the effect of intravenous vitamin C versus placebo in patients with incurable non-small cell lung cancer. Participants in both arms will be receiving platinum doublet chemotherapy with or without concurrent immunotherapy as standard care. We plan to enroll 90 patients over 5 years.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ascorbic acid | Drug | — | UNRESOLVED |
| Normal Saline | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intravenous Vitamin C
- description
- 1g/kg IVC administered twice weekly for 6 months.
- interventionNames
- Drug: Ascorbic acid
- type
- PLACEBO_COMPARATOR
- label
- Normal Saline
- description
- Equivalent volume normal saline administered twice weekly for 6 months.
- interventionNames
- Other: Normal Saline
Primary outcomes (1)
- measure
- Change in Quality of Life
- timeFrame
- Baseline, Chemo cycles 1-4, 6 months, 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults (≥18 years of age) seen at TOHCC with stage IIIB or IV primary non-small cell lung cancer 2. Eligible and scheduled for first line platinum-doublet chemotherapy with or without concurrent immunotherapy Exclusion Criteria: 1. ECOG status greater than 2 2. Previously received IVC within 6 months prior to randomization 3. Biochemical deficiency in G6PD 4. Estimated Glomerular Filtration Rate (eGFR) less than 45 mL/min 5. Currently taking insulin or warfarin 6. History of severe renal dysfunction or hemochromatosis 7. Previously undergone cytotoxic chemotherapy or immunotherapy within 12 months prior to randomization 8. If pregnant or planning to become pregnant: not a carrier of the gene for G6PD deficiency 9. Currently taking an investigational product or participation in an investigational study within the past 30 days 10. Any reason which, under the discretion of the Principal Investigator or delegate, would preclude the patient from participating
References
Publications (0)
Data not yet available
No reference posted for this study.