Lung CancerPhase 2AIVAANCT05849129
Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Ascorbic acid and Normal Saline in people with Lung Cancer, run by The Canadian College of Naturopathic Medicine at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Ascorbic acid and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2024to 24 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer: A Double Blind, Placebo Controlled, Phase II Randomized Controlled Trial
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.
- Conditions
- Lung Cancer
- Being tested
- Ascorbic acid, Normal Saline
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic acidDrug
Also called Vitamin C
High dose ascorbic acid delivered intravenously
Normal SalineOther
Also called Sodium Chloride Solution
0.9% NaCl solution
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Vitamin C | Experimental | 1g/kg IVC administered twice weekly for 6 months. Receives: Drug: Ascorbic acid |
| Normal Saline | Placebo comparator | Equivalent volume normal saline administered twice weekly for 6 months. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Chemo cycles 1-4, 6 months, 12 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Survival
The incidence of all cause mortality will be compared between arms.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 Oct 2024
- Primary completion24 Sep 2026
- Study completion24 Sep 2026
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Canadian College of Naturopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849129
- Sponsor's protocol ID
- 20220721-01H
- Acronym
- AIVAA
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer: A Double Blind, Placebo Controlled, Phase II Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05849129
- Acronym / sponsor ID
- AIVAA / 20220721-01H
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Canadian College of Naturopathic MedicineUniversity, hospital or other
- Collaborators
- Ottawa Hospital Research Institute
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 24 Sep 2026 (actual)
- Study completion
- 24 Sep 2026 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Vitamin C | Experimental | Drug: Ascorbic acid1g/kg IVC administered twice weekly for 6 months. |
| Normal Saline | Placebo comparator | Other: Normal SalineEquivalent volume normal saline administered twice weekly for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic acidAlso: Vitamin CHigh dose ascorbic acid delivered intravenously | Drug | Intravenous Vitamin C |
| Normal SalineAlso: Sodium Chloride Solution0.9% NaCl solution | Other | Normal Saline |
Primary outcome
Change in Quality of Life
Time frame: 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.
8 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ascorbic acid and Normal Saline in people with Lung Cancer, run by The Canadian College of Naturopathic Medicine at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (time frame: Baseline, Chemo cycles 1-4, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.