Active not recruitingNAINTERVENTIONAL

A Nutritional Supplement to Support People With Non-small Cell Lung Cancer

This study is for people with non-small cell lung cancer, a type of lung cancer. Sometimes, people with this condition can have trouble getting enough nutrients. Researchers want to see if a special nutritional supplement can help people respond better to their cancer treatments, such as immunotherapy or a combination of immunotherapy and chemotherapy. Participants will either receive the nutritional supplement or a placebo (a dummy pill with no active ingredients) alongside their usual cancer care. This helps researchers properly compare the effects. The study involves taking capsules daily, having regular check-ups, and filling out health questionnaires to understand how the supplement might affect their well-being and treatment.

At a glance

Status

Active not recruiting

Phase

Sponsor

AHS Cancer Control Alberta

Enrolment target

Start

19 Dec 2022

Estimated completion

01 Dec 2025

Non-small Cell Lung Cancer

What is this study about?

This research study is looking into whether a specific nutritional supplement can help people with non-small cell lung cancer. This is a common type of lung cancer, and sometimes patients can struggle with getting all the nutrients they need, especially when undergoing treatment. The main goal of this study is to understand if this supplement can improve how well patients respond to their standard cancer treatments, such as immunotherapy, or a combination of immunotherapy and chemotherapy.

To make sure the study results are clear and reliable, some participants will receive the actual nutritional supplement, while others will receive a 'placebo.' A placebo looks exactly like the real supplement but doesn't contain any active ingredients. This allows the researchers to compare the two groups and see if any changes are truly due to the supplement or just other factors. This way, we can learn more about how nutrition might play a role in supporting cancer treatment.

Participants will take capsules daily throughout their cancer treatment period. Over time, doctors will conduct various checks, including physical exams, blood tests, and scans, to see how the participants are doing. They will also ask about their quality of life. This information will help the researchers determine if the nutritional supplement makes a difference in how patients manage their cancer and respond to treatment.

Key takeaways

This study evaluates a nutritional supplement for non-small cell lung cancer.
It aims to see if the supplement improves response to immunotherapy/chemotherapy.
Participants will take either the supplement or a placebo daily.
Close monitoring, including physical exams, scans, and blood tests, will occur.
Participation involves regular clinic visits and health questionnaires.
You can leave the study at any time without affecting your care.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with an advanced form of non-small cell lung cancer (stage IIIB/IV) that can't be cured or has spread. You must be planning to receive immunotherapy, chemotherapy, or both, and your cancer shouldn't have specific genetic changes called EGFR and ALK mutations. If you've had previous chemotherapy or immunotherapy for early-stage cancer, you might still be able to join if it was at least 12 months ago.

There are also some important reasons why you might not be able to join. For example, if you've been diagnosed with another cancer in the last two years (unless it was a very mild skin or bladder cancer that has been successfully treated), or if your doctor believes your life expectancy is less than six months. Also, if you're already taking a supplement similar to the one being studied, or have severe allergies to ingredients in the study product, you wouldn't be able to participate.

It's important that you understand what the study involves, are able to read and sign an informed consent form, and are willing to follow all the study instructions. The research team will review all your medical information carefully to see if this study is suitable for you.

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 without specific genetic changes (EGFR/ALK)?
Are you starting or receiving immunotherapy, chemotherapy, or both?
Have you not had a recent diagnosis of another serious cancer (in the last 2 years)?
Are you able to agree to the study rules and attend appointments?
Are you not currently taking a supplement similar to the one being studied?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance (like flipping a coin) to one of two groups. One group will take the nutritional supplement, and the other will take the placebo. Both groups will continue to receive their standard cancer treatment (immunotherapy or immunotherapy and chemotherapy).

You will need to take 5 capsules by mouth every day. You'll start taking them on the first day of your cancer treatment and continue until your immunotherapy or chemotherapy treatment is finished. You'll also need to keep a diary of when you take your capsules.

During your time in the study, you'll have several check-ups. These will include a physical examination, measuring your height and weight, and assessing how your cancer treatment is affecting your daily life. Doctors will also keep track of any other medications you're taking and any side effects you might experience. You'll have regular CT scans (special X-rays that create detailed pictures inside your body), give blood samples, and fill out questionnaires about your quality of life. The doctors will explain the full schedule of visits and tests.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. You might benefit if the nutritional supplement helps improve your response to treatment or your general well-being, but there's no guarantee the supplement will help you personally. As with any medication, there's a chance of side effects from the supplement or placebo, although these will be carefully monitored. You'll receive comprehensive medical care throughout the study, and your health will be closely watched. Remember, joining this study is completely your choice, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Cross Cancer Institute
Verified postcode
Edmonton, Canada

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer. This study is for people with an advanced form of it.

What is a placebo?

A placebo is a 'dummy pill' that looks like the real treatment but has no active ingredients. It helps researchers compare results fairly.

Will I know if I'm getting the supplement or the placebo?

No, you won't know which one you're receiving during the study. This helps ensure unbiased results.

How long will I be in the study?

You'll take the capsules from the start of your immunotherapy/chemotherapy until those treatments finish. The exact duration will depend on your treatment plan.

Can I stop participating if I want to?

Yes, absolutely. You can leave the study at any time, for any reason, and it won't affect your ongoing medical care.