RecruitingPHASE2INTERVENTIONAL

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

This study is looking at whether giving high-dose vitamin C directly into the veins, along with standard chemotherapy, can help people with advanced non-small cell lung cancer. The usual treatment includes chemotherapy, and sometimes immunotherapy. We want to see if adding vitamin C makes a difference compared to adding a dummy treatment (placebo). About 90 patients will take part over five years. All participants will receive their regular cancer treatment. The aim is to understand if this extra treatment could be beneficial for those with lung cancer that cannot be cured. We are not making any medical recommendations, only exploring a potential approach.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

The Canadian College of Naturopathic Medicine

Enrolment target

Start

01 Oct 2024

Estimated completion

01 Oct 2031

Lung Cancer

What is this study about?

This study is about seeing if adding a special type of vitamin C treatment could help people with advanced non-small cell lung cancer. When we say 'advanced', it means the cancer has spread and can't be completely cured with surgery. Patients in this study will already be getting the usual care for their cancer, which is typically a combination of powerful medicines called chemotherapy, and sometimes another type of treatment called immunotherapy.

Researchers want to find out if giving high doses of vitamin C directly into the bloodstream, in addition to these standard treatments, makes a difference. One group of patients will receive the vitamin C, while another group will receive a dummy treatment, called a placebo. This helps the researchers fairly compare the effects of the vitamin C. The vitamin C is given through an 'intravenous' drip, meaning it goes straight into a vein.

The main goal is to understand if this extra vitamin C treatment can improve how well other treatments work or help patients feel better. It's important to remember that this is a study to learn more; it's not a recommendation for treatment. All participants will continue to receive the care their doctors believe is best for their cancer.

Key takeaways

This study is testing high-dose intravenous vitamin C for advanced lung cancer.
It's an add-on treatment to standard chemotherapy and immunotherapy.
You would either get vitamin C or a dummy treatment (placebo).
All participants will receive their usual cancer care.
The study aims to see if vitamin C can help improve outcomes.
It's a research study, not a guaranteed treatment.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) with a type of lung cancer called non-small cell lung cancer, which is advanced (meaning it's stage IIIB or IV). You must also be planning to start your first round of standard chemotherapy, which might also include immunotherapy.

There are certain reasons why you might not be able to join. For example, if you've already had vitamin C given into your veins in the last six months, or if you have certain health conditions like severe kidney problems, a condition called hemochromatosis, or a specific genetic problem called G6PD deficiency. Also, if you're currently taking insulin or certain blood thinners like warfarin, or if your overall health is not strong enough (judged by your doctor), you might not be suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced non-small cell lung cancer?
Are you about to start your first chemotherapy treatment (with or without immunotherapy)?
Have you NOT had intravenous vitamin C in the last 6 months?
Do you NOT have severe kidney problems or a specific genetic condition called G6PD deficiency?
Are you NOT currently taking insulin or blood thinners like warfarin?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly put into one of two groups: one receiving vitamin C into your vein, and the other receiving a dummy treatment (placebo) into your vein. Neither you nor your doctor will know which one you are getting. You will continue to have your standard chemotherapy, and potentially immunotherapy, as planned by your cancer care team. The vitamin C or placebo would be given as an extra treatment. You would have regular check-ups, blood tests, and scans, similar to what you'd have during your regular cancer treatment, to see how you're responding and how you're feeling. The study will last for as long as your treatment course, with follow-ups afterwards. The hospital staff will explain all the appointments and tests in detail.

Potential risks and benefits

Participating in a study like this might offer a potential benefit if the vitamin C treatment proves effective, though there's no guarantee. You would receive close medical attention throughout. However, there are potential risks associated with any new treatment, including side effects from the vitamin C or interactions with your other medications, although vitamin C is generally considered safe. The dummy treatment (placebo) itself carries very little risk. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

The Ottawa Hospital
Verified postcode
Ottawa, Canada· Recruiting

Common questions

What is 'non-small cell lung cancer'?

It's the most common type of lung cancer. 'Advanced' means it has spread and can't be fully cured with surgery.

What is 'chemotherapy'?

It's a powerful medicine that kills cancer cells. Immunotherapy helps your own body fight the cancer.

What is 'intravenous vitamin C'?

It means vitamin C given directly into your bloodstream through a drip, at a higher dose than you'd get from food or tablets.

What is a 'placebo'?

It's a dummy treatment that looks like the real thing, but has no active medicine. It helps researchers compare effects fairly.

Will I still get my regular cancer treatment?

Yes, absolutely. Everyone in the study will receive their planned chemotherapy and any other standard care.

How to find out more

Dugald Seely, ND, MSc

dseely@thechi.ca 613-792-1222 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.