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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
90
High dose ascorbic acid delivered intravenously
0.9% NaCl solution
The Ottawa Hospital
Ottawa, Ontario, Canada
RECRUITINGChange in Quality of Life
Participant reported quality of life (QOL) measured using the Functional Assessment of Cancer Therapy - Lung (FACT-L). FACT-L is a validated tool for assessing QOL in patients with lung cancer. FACT scores are normalized to values between 0-100, where 0 is the worst QOL and 100 is the best QOL imaginable. Each chemotherapy cycle is 3 weeks in length.
Time frame: Baseline, Chemo cycles 1-4, 6 months, 12 months
Chemotherapy-Related Toxicities
Frequency of adverse events (AE) which are commonly experienced by patients undergoing chemotherapy. Measured using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). 31 symptoms were selected by the investigators.
Time frame: 12 months
Frequency of Discontinuation of Chemotherapy
Patients often discontinue chemotherapy due to side effects. The investigators will monitor the incidence of stopping chemotherapy and compare the number of patients who stop chemotherapy in both arms.
Time frame: 6 months
Change in General Symptom Burden
Measured using the Edmonton Symptom Assessment Scale, which measures 9 symptoms commonly experienced by cancer patients. Each symptom is rated on a scale of 0-10, where 0 is the best symptom and 10 is the worst symptom. Each chemotherapy cycle is 3 weeks in length.
Time frame: Baseline, chemo cycles 1-4, 6 months, 12 months
Change in C-Reactive Protein Levels
The investigators will monitor the changes in C-reactive protein (CRP), a common indicator of systemic inflammation. Mean changes in CRP will be compared between arms. Each chemotherapy cycle is 3 weeks in length.
Time frame: Baseline, chemo cycles 1-4, 6 months, 12 months
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Tumour Progression
The investigators will monitor tumour progression using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, which measures the incidence of complete response, partial response, stable disease, and progressive disease during treatments.
Time frame: 12 months
Survival
The incidence of all cause mortality will be compared between arms.
Time frame: 24 months
Safety
The investigators will monitor the incidence of all adverse events in both arms to add to the safety profile of IVC in this population.
Time frame: 6 months
Cytotoxicity
The investigators will assess the ability of IVC to bring serum ascorbate levels to at least 15mM, which is the hypothesized level at which cytotoxic effects may occur. Levels 15mM or above will be considered adequate.
Time frame: 12 months