Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ascorbic acid, Normal Saline.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer: A Double Blind, Placebo Controlled, Phase II Randomized Controlled Trial
Overview
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.
Interventions
- Drug Ascorbic acid
High dose ascorbic acid delivered intravenously - Other Normal Saline
0.9% NaCl solution
Primary outcome measures
- Change in Quality of Life [Time frame: Baseline, Chemo cycles 1-4, 6 months, 12 months]
Secondary outcome measures (8)
- Chemotherapy-Related Toxicities [Time frame: 12 months]
- Frequency of Discontinuation of Chemotherapy [Time frame: 6 months]
- Change in General Symptom Burden [Time frame: Baseline, chemo cycles 1-4, 6 months, 12 months]
- Change in C-Reactive Protein Levels [Time frame: Baseline, chemo cycles 1-4, 6 months, 12 months]
- Tumour Progression [Time frame: 12 months]
- Survival [Time frame: 24 months]
- Safety [Time frame: 6 months]
- Cytotoxicity [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Canada · 1 center
- The Ottawa Hospital — Ottawa
Identifiers
NCT: NCT05849129 · 20220721-01H