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

NCT ID: NCT05849129

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2031-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intravenous Vitamin C

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

Group Type EXPERIMENTAL

Ascorbic acid

Intervention Type DRUG

High dose ascorbic acid delivered intravenously

Normal Saline

Equivalent volume normal saline administered twice weekly for 6 months.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

0.9% NaCl solution

Interventions

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Ascorbic acid

High dose ascorbic acid delivered intravenously

Intervention Type DRUG

Normal Saline

0.9% NaCl solution

Intervention Type OTHER

Other Intervention Names

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Vitamin C Sodium Chloride Solution

Eligibility Criteria

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Inclusion Criteria

1. Adults (≥18 years of age) seen at TOHCC with stage IIIB or IV primary non-small cell lung cancer
2. Eligible and scheduled for first line platinum-doublet chemotherapy with or without concurrent immunotherapy

Exclusion Criteria

1. ECOG status greater than 2
2. Previously received IVC within 6 months prior to randomization
3. Biochemical deficiency in G6PD
4. Estimated Glomerular Filtration Rate (eGFR) less than 45 mL/min
5. Currently taking insulin or warfarin
6. History of severe renal dysfunction or hemochromatosis
7. Previously undergone cytotoxic chemotherapy or immunotherapy within 12 months prior to randomization
8. If pregnant or planning to become pregnant: not a carrier of the gene for G6PD deficiency
9. Currently taking an investigational product or participation in an investigational study within the past 30 days
10. Any reason which, under the discretion of the Principal Investigator or delegate, would preclude the patient from participating
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Hospital Research Institiute

UNKNOWN

Sponsor Role collaborator

The Canadian College of Naturopathic Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Dugald Seely, ND, MSc

Role: CONTACT

613-792-1222 ext. 2

Mark Legacy, BSc, CCRP

Role: CONTACT

613-792-1222 ext. 1

Facility Contacts

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Paul Wheatley-Price, MD

Role: primary

Other Identifiers

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20220721-01H

Identifier Type: -

Identifier Source: org_study_id

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