AIVAA: Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intravenous Vitamin C 1g/kg IVC administered twice weekly for 6 months. |
Drug: Ascorbic acid
High dose ascorbic acid delivered intravenously
Other Names:
|
| Placebo Comparator: Normal Saline Equivalent volume normal saline administered twice weekly for 6 months. |
Other: Normal Saline
0.9% NaCl solution
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Quality of Life [Baseline, Chemo cycles 1-4, 6 months, 12 months]
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.
Secondary Outcome Measures
- Chemotherapy-Related Toxicities [12 months]
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.
- Frequency of Discontinuation of Chemotherapy [6 months]
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.
- Change in General Symptom Burden [Baseline, chemo cycles 1-4, 6 months, 12 months]
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.
- Change in C-Reactive Protein Levels [Baseline, chemo cycles 1-4, 6 months, 12 months]
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.
- Tumour Progression [12 months]
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.
- Survival [24 months]
The incidence of all cause mortality will be compared between arms.
- Safety [6 months]
The investigators will monitor the incidence of all adverse events in both arms to add to the safety profile of IVC in this population.
- Cytotoxicity [12 months]
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.
Eligibility Criteria
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:
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ECOG status greater than 2
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Previously received IVC within 6 months prior to randomization
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Biochemical deficiency in G6PD
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Estimated Glomerular Filtration Rate (eGFR) less than 45 mL/min
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Currently taking insulin or warfarin
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History of severe renal dysfunction or hemochromatosis
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Previously undergone cytotoxic chemotherapy or immunotherapy within 12 months prior to randomization
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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
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Any reason which, under the discretion of the Principal Investigator or delegate, would preclude the patient from participating
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The Canadian College of Naturopathic Medicine
- Ottawa Hospital Research Institiute
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20220721-01H