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Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer

ConditionLung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Canadian College of Naturopathic Medicine

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ascorbic acid

    Drug

    High dose ascorbic acid delivered intravenously

  • Normal Saline

    Other intervention

    0.9% NaCl solution

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Intravenous Vitamin CExperimental treatment 1 intervention
Group B: Normal SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Chemo cycles 1-4, 6 months, 12 months

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Canadian College of Naturopathic Medicine

Lead sponsor

Ottawa Hospital Research Institute

Collaborator

Source ClinicalTrials.gov
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