Recruiting
Phase 2

Ascorbic Acid

Sponsor:

The Canadian College of Naturopathic Medicine

Code:

NCT05849129

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ascorbic acid

Normal Saline

Study Details

Brief summary:

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

Lung Cancer

Study ID

NCT05849129

Start date

Oct 1, 2024

Status verified date

Jan, 2026

Completion date

Oct 1, 2031

Anticipated

Primary completion date

Oct 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intravenous Vitamin C

1g/kg IVC administered twice weekly for 6 months.

placebo comparator: Normal Saline

Equivalent volume normal saline administered twice weekly for 6 months.

Interventions

Ascorbic acid

High dose ascorbic acid delivered intravenously

Normal Saline

0.9% NaCl solution

Primary outcome measure

  • Change in Quality of Life [ Time Frame: Baseline, Chemo cycles 1-4, 6 months, 12 months ]

Central Contacts and Locations

Central contacts

Dugald Seely, ND, MSc

613-792-1222dseely@thechi.ca

Mark Legacy, BSc, CCRP

613-792-1222mlegacy@thechi.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H8L6

Contacts

Paul Wheatley-Price, MD

pwheatleyprice@toh.ca

More Information

Sponsor

The Canadian College of Naturopathic Medicine

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Canadian College of Naturopathic Medicine on 2026-01-23.