Using intravenous vitamin C for advanced lung cancer treatment
Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer: A Double Blind, Placebo Controlled, Phase II Randomized Controlled Trial
This study is testing if giving vitamin C through an IV can help people with advanced lung cancer feel better while they are getting their usual chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Canadian College of Naturopathic Medicine Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT05849129 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intravenous ascorbic acid compared to a placebo in patients with advanced non-small cell lung cancer who are receiving standard platinum doublet chemotherapy with or without immunotherapy. The study aims to enroll 90 patients over a period of five years, assessing the potential benefits of vitamin C as an adjunctive treatment. Participants will be randomly assigned to receive either the vitamin C treatment or a placebo while undergoing their chemotherapy regimen.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage IIIB or IV non-small cell lung cancer who are scheduled for first-line platinum-doublet chemotherapy.
Not a fit: Patients with severe renal dysfunction, certain biochemical deficiencies, or those currently on specific medications like insulin or warfarin may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance the effectiveness of chemotherapy and improve outcomes for patients with advanced lung cancer.
How similar studies have performed: While the use of intravenous vitamin C in cancer treatment has been explored in various studies, this specific approach in conjunction with platinum doublet chemotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ottawa, Ontario
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Dugald Seely, ND, MSc
- Email: dseely@thechi.ca
- Phone: 613-792-1222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.