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

Lung Cancer Clinical Trial

— AIVAA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05849129
• Other study ID #: 20220721-01H
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 1, 2024
• Est. completion date: February 1, 2031

Study information

• Verified date: December 2023
• Source: The Canadian College of Naturopathic Medicine
• Contact: Dugald Seely, ND, MSc
• Phone: 613-792-1222
• Email: dseely[@]thechi.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: February 1, 2031
• Est. primary completion date: February 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Ascorbic acid
High dose ascorbic acid delivered intravenously

Other:
• Normal Saline
0.9% NaCl solution

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Canadian College of Naturopathic Medicine	Ottawa Hospital Research Institiute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 months
Secondary	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.	6 months
Secondary	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.	Baseline, chemo cycles 1-4, 6 months, 12 months
Secondary	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.	Baseline, chemo cycles 1-4, 6 months, 12 months
Secondary	Tumour Progression	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.	12 months
Secondary	Survival	The incidence of all cause mortality will be compared between arms.	24 months
Secondary	Safety	The investigators will monitor the incidence of all adverse events in both arms to add to the safety profile of IVC in this population.	6 months
Secondary	Cytotoxicity	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.	12 months