RecruitingPhase 2NCT05849129

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

Sponsor

The Canadian College of Naturopathic Medicine

Enrollment

90 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Cancer

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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 Criteria10

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