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

NCT05849129 | Recruiting Phase 2 DMC

• 1 other identifier: 20220721-01H
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

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.

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

Secondary Outcomes (8)

• Chemotherapy-Related Toxicities

  12 months

• Frequency of Discontinuation of Chemotherapy

  6 months

• Change in General Symptom Burden

  Baseline, chemo cycles 1-4, 6 months, 12 months

• Change in C-Reactive Protein Levels

  Baseline, chemo cycles 1-4, 6 months, 12 months

• Tumour Progression

  12 months

Study Arms (2)

Intravenous Vitamin C

EXPERIMENTAL

1g/kg IVC administered twice weekly for 6 months.

Drug: Ascorbic acid

Normal Saline

PLACEBO COMPARATOR

Equivalent volume normal saline administered twice weekly for 6 months.

Other: Normal Saline

Interventions

Ascorbic acid DRUG

High dose ascorbic acid delivered intravenously

Also known as: Vitamin C

Intravenous Vitamin C

Normal Saline OTHER

0.9% NaCl solution

Also known as: Sodium Chloride Solution

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Canadian College of Naturopathic Medicine: lead
• Ottawa Hospital Research Institiute: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Ascorbic Acid; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Dugald Seely, ND, MSc

CONTACT

613-792-1222; dseely@thechi.ca

Mark Legacy, BSc, CCRP

CONTACT

613-792-1222; mlegacy@thechi.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 8, 2023
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2031
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)