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NCT Number: NCT05849129

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

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.

Recruiting

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location status: Recruiting

Location contact

Paul Wheatley-Price, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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
  • 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

Treatment and study plan

ascorbic acid

Drug

High dose ascorbic acid delivered intravenously

Other names: Vitamin C

Normal Saline

Other

0.9% NaCl solution

Other names: Sodium Chloride Solution

Primary outcomes

  1. 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.

Secondary outcomes

  1. Chemotherapy-Related Toxicities

    Time frame: 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.

  2. Frequency of Discontinuation of Chemotherapy

    Time frame: 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.

  3. Change in General Symptom Burden

    Time frame: 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.

  4. Change in C-Reactive Protein Levels

    Time frame: 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.

  5. Tumour Progression

    Time frame: 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.

  6. Survival

    Time frame: 24 months

    The incidence of all cause mortality will be compared between arms.

  7. Safety

    Time frame: 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.

  8. Cytotoxicity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dugald Seely, ND, MSc

CONTACT

[email protected]

613-792-1222 ext. 2

Mark Legacy, BSc, CCRP

CONTACT

[email protected]

613-792-1222 ext. 1

Sponsors and collaborators

Lead sponsor

The Canadian College of Naturopathic Medicine

Other

Collaborators

  • Ottawa Hospital Research Institute

Registry information

Official study title

Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer: A Double Blind, Placebo Controlled, Phase II Randomized Controlled Trial

Acronym: AIVAA

Important dates

Study start
2024
Primary completion
2030
Study completion
2031
First posted
May 8, 2023
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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