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Not yet recruitingNAINTERVENTIONAL

Breast Cancer Plasma Adjuvant Intra-operative Treatment (Breast Cancer PAINT)

This study, called 'Breast Cancer PAINT', is exploring a new way to treat breast cancer after surgery. When a breast tumour is removed (a lumpectomy), there's a chance some cancer cells might be left behind, leading to the cancer returning. This trial investigates a treatment called 'non-thermal plasma' (NTP), which is a special kind of gas. After a tumour is taken out, the doctors will apply NTP to the area where the tumour was. They want to find the safest amount of NTP to use, check for any unwanted side effects, and see if it makes a difference to how the breast looks afterwards. The hope is that NTP could help reduce the risk of breast cancer coming back in the future.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrolment target
30
Start
01 Sep 2024
Estimated completion
01 Jan 2026

What is this study about?

This study is investigating a new approach to help women who have had breast cancer surgery. After a breast tumour is removed, especially with a lumpectomy (where only part of the breast is removed), there's always a small chance that some cancer cells might still be in the area. This can sometimes lead to the cancer returning in the same place. Currently, patients often have radiotherapy to try and lower this risk.

This trial is looking at something called 'non-thermal plasma' (NTP). Think of plasma as a special kind of gas. Scientists have found that NTP might be able to target and destroy cancer cells. The idea is to apply this NTP treatment directly to the area where the tumour was removed, right after the surgery.

The main goals of this study are to find out if this NTP treatment is safe for breast cancer patients, and to work out the best amount (or 'dose') to use. Researchers will also be checking for any side effects and how the treated area of the breast looks after the treatment. By doing this, they hope to see if NTP could be a helpful new way to reduce the chance of breast cancer coming back after surgery.

Key takeaways

  • This study is testing a new treatment called non-thermal plasma (NTP) for breast cancer.
  • NTP is applied to the area where the tumour was removed during surgery.
  • The main goals are to check how safe NTP is and to find the right amount to use.
  • It could potentially help reduce the chance of cancer returning after surgery.
  • Participation involves monitoring for 3 months after surgery.
  • You must be having a lumpectomy to be eligible for this study.

Who may be eligible?

To join this study, you would need to be at least 18 years old and be diagnosed with breast cancer. Importantly, you would need to be planning to have a 'lumpectomy' – which is an operation where only the tumour and a small amount of surrounding breast tissue are removed, rather than the whole breast.

There are also some reasons why you might not be able to join. For example, if you've already had treatment like chemotherapy or radiotherapy for this particular cancer, or if you're planning to have radiotherapy during your operation, you wouldn't be able to take part. Also, if you have certain health conditions like diabetes, or other conditions that affect your immune system or require you to take high doses of certain medications, you might not be eligible. They will also need to check if you are pregnant, as pregnant women cannot participate.

Your study doctor will discuss all these points with you in detail to see if this study is right for your situation.

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.

  1. Are you 18 years or older?
  2. Do you have breast cancer?
  3. Are you scheduled to have a lumpectomy (part of the breast removed)?
  4. Have you NOT had previous chemotherapy or radiotherapy for this cancer?
  5. Do you NOT have diabetes or certain immune conditions?
  6. Are you NOT pregnant?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the non-thermal plasma (NTP) treatment during your breast cancer surgery, after the tumour has been removed. This is a one-off treatment right there in the operating room. After the treatment, you wouldn't need to take any special medication related to the study.

The research team will then follow your progress for about 3 months after your surgery. During this time, they will check on your health and recovery, looking for any side effects or changes. This will involve physical examinations by the doctors, some laboratory tests (like blood tests), and answering questionnaires about how you feel and how your breast looks. They may also take photos of the treated area to see the cosmetic outcome. The exact number of visits will be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial can offer the potential benefit of accessing new treatments that aren't yet widely available, and you would be contributing to medical research that could help others. However, like all medical treatments, there's always a chance of side effects or that the treatment may not work as expected. The purpose of this study is specifically to assess safety and find the right dose of this new treatment. You will be closely monitored for any unwanted effects. It's very important to remember that joining a study is always your choice, and you are free to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Centre Hospitalier de l'Université de Montréal - CHUM
    Verified postcode
    Montreal, Canada

Common questions

What is 'non-thermal plasma'?

It's a special kind of gas that scientists believe might be able to kill cancer cells, and this study wants to see if it's safe to use after breast cancer surgery.

Will I still need a lumpectomy if I join this study?

Yes, you would still have your standard lumpectomy operation to remove the breast tumour as planned.

How long will I be involved in the study?

You'll have the treatment during your surgery, and then the research team will follow your progress for about 3 months afterwards.

What does 'cosmetic effects' mean in this study?

It means the doctors will be looking at how the treated area of your breast looks after the surgery and treatment, and you'll be asked about your satisfaction with its appearance.

Will I know if I'm getting the treatment?

Yes, if you meet the criteria for the treatment groups, the non-thermal plasma will be applied to the area where your tumour was removed during your surgery.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Breast Cancer Plasma Adjuvant Intra-operative Treatment (Bre…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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