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| Name | Class |
|---|---|
| Ottawa Hospital Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Vitamin C | Experimental | 1g/kg IVC administered twice weekly for 6 months. |
|
| Normal Saline | Placebo Comparator | Equivalent volume normal saline administered twice weekly for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascorbic acid | Drug | High dose ascorbic acid delivered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change 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. | Baseline, Chemo cycles 1-4, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dugald Seely, ND, MSc | Contact | 613-792-1222 | 2 | dseely@thechi.ca |
| Mark Legacy, BSc, CCRP | Contact | 613-792-1222 | 1 | mlegacy@thechi.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Recruiting | Ottawa | Ontario | K1H8L6 | Canada |
Individual participant data will not be shared with other researchers. Cumulative data not present in the manuscript or on this website may be shared upon request.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Normal Saline | Other | 0.9% NaCl solution |
|
|
| 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. |
| 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. | 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. | Baseline, chemo cycles 1-4, 6 months, 12 months |
| 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. | 12 months |
| Survival | The incidence of all cause mortality will be compared between arms. | 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. | 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. | 12 months |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |