Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer
Recruiting · NCT05849129 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Ascorbic acidNormal Saline
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Adults (≥18 years of age) seen at TOHCC with stage IIIB or IV primary non-small cell lung cancer
- Eligible and scheduled for first line platinum-doublet chemotherapy with or without concurrent immunotherapy
Exclusion criteria
- ECOG status greater than 2
- Previously received IVC within 6 months prior to randomization
- Biochemical deficiency in G6PD
- Estimated Glomerular Filtration Rate (eGFR) less than 45 mL/min
- Currently taking insulin or warfarin
- History of severe renal dysfunction or hemochromatosis
- Previously undergone cytotoxic chemotherapy or immunotherapy within 12 months prior to randomization
- If pregnant or planning to become pregnant: not a carrier of the gene for G6PD deficiency
- Currently taking an investigational product or participation in an investigational study within the past 30 days
- Any reason which, under the discretion of the Principal Investigator or delegate, would preclude the patient from participating
Where it is running
1 location listed.
- The Ottawa Hospital - Ottawa, Ontario, Canada