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Trial Title:
Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer
NCT ID:
NCT05849129
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Ascorbic Acid
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Ascorbic acid
Description:
High dose ascorbic acid delivered intravenously
Arm group label:
Intravenous Vitamin C
Other name:
Vitamin C
Intervention type:
Other
Intervention name:
Normal Saline
Description:
0.9% NaCl solution
Arm group label:
Normal Saline
Other name:
Sodium Chloride Solution
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 1, 2024
Completion date:
October 1, 2031
Lead sponsor:
Agency:
The Canadian College of Naturopathic Medicine
Agency class:
Other
Collaborator:
Agency:
Ottawa Hospital Research Institiute
Agency class:
Other
Source:
The Canadian College of Naturopathic Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05849129
