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

The Canadian College of Naturopathic Medicine

Status and phase: Enrolling; Phase 2

Conditions: Lung Cancer

Treatments: Drug: Ascorbic acid; Other: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05849129

20220721-01H

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Intravenous Vitamin C

Experimental group

Description:

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

Treatment:

Drug: Ascorbic acid

Normal Saline

Placebo Comparator group

Description:

Equivalent volume normal saline administered twice weekly for 6 months.

Treatment:

Other: Normal Saline