Active not recruitingNAINTERVENTIONAL

Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.

This study is for women who have had breast reconstruction surgery using a muscle from their back (called a latissimus dorsi flap) after having breast cancer surgery. Doctors want to understand how this operation affects the strength and movement of the arm and shoulder. They will check muscle function before the surgery and then again at 3, 6, and 12 months afterwards. The study uses various tests, including physical assessments and questionnaires, to get a full picture. The aim is to see if any weakness after surgery improves over time, ideally returning to normal function within 6 to 12 months. This helps doctors improve care for future patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre Georges Francois Leclerc

Enrolment target

Start

25 Nov 2022

Estimated completion

04 Dec 2026

Breast Cancer

What is this study about?

This study is designed for women who have had or are planning to have breast reconstruction surgery after breast cancer. Specifically, it focuses on a type of reconstruction that uses a muscle from your back, called the latissimus dorsi flap. After removing a breast due to cancer, this muscle is sometimes moved to create a new breast shape. Doctors want to understand how this surgery affects the strength and movement in your arm and shoulder on the side where the muscle was taken.

The main goal is to measure how well this back muscle works before the surgery and then at different times afterwards: 3 months, 6 months, and 12 months. They will use a variety of ways to check this, including gentle physical tests and asking you to fill out questionnaires about your daily activities and quality of life. This helps them get a complete picture of how the surgery impacts your body.

They expect that after the surgery, there might be a bit of weakness or difficulty with certain arm movements, especially around 3 months. However, the hope is that by 6 to 12 months after the operation, your muscle function will return to how it was before the surgery. By gathering this information, researchers can learn more about this type of breast reconstruction and help make future care even better for women undergoing this procedure.

Key takeaways

The study looks at arm and shoulder movement after breast reconstruction using a back muscle.
It measures muscle function before surgery and up to 12 months afterwards.
Participation involves physical tests and questionnaires at different time points.
The aim is to see if any weakness after surgery improves over time.
Information from this study could help improve future breast reconstruction care.

Who may be eligible?

This study is looking for women aged between 18 and 80 who have had or are going to have breast reconstruction using a specific back muscle (the latissimus dorsi flap) after having surgery for breast cancer on one side. You'll need to have had a clear breast check (like a mammogram or ultrasound) in the last six months, and also be able to understand and sign a consent form, showing you’re happy to take part.

However, there are some reasons why you might not be able to join the study. For example, if your cancer has spread to other parts of your body, or if you have other health issues that would make it hard for you to answer questions or do physical tests. You also wouldn't be able to join if you've already had a problem with a previous breast reconstruction, or if you've had breast cancer or reconstruction on the other breast. Lastly, you'll need to be able to use the internet to connect to some study software.

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 between 18 and 80 years old?
Are you having breast reconstruction on one side, using a back muscle, after breast cancer surgery?
Have you had a normal breast check (like a mammogram) in the last 6 months?
Do you have internet access to use a specific software?
Have you *not* had breast cancer or reconstruction on your other breast?
Is your cancer *not* currently spread to other parts of your body?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have several appointments. Before your breast reconstruction surgery, you'll have some tests to measure your muscle strength and movement. After the surgery, you'll come back for follow-up appointments at 3 months, 6 months, and 12 months. At each visit, you'll have similar tests to check your muscle function and strength. You'll also be asked to fill out questionnaires about how you're feeling and how the surgery has affected your daily life. You'll need internet access to use a specific software called "Exolis" for some of these activities. The total duration of your participation in the study would be about 12 months after your surgery.

Potential risks and benefits

Taking part might give you a better understanding of your own recovery process. Your involvement will also help doctors learn more about breast reconstruction surgery, potentially improving care for future patients. As with any medical study, there's a small risk of discomfort from the physical tests, and answering questionnaires can take time. You are always free to withdraw from the study at any point, for any reason, without it affecting your medical care.

Locations (1)

Centre Georges-François Leclerc
Verified postcode
Dijon, France

Common questions

What is a 'minimally invasive latissimus dorsi flap'?

It's a type of breast reconstruction surgery where a muscle from your back (the latissimus dorsi) is carefully moved to rebuild your breast after cancer surgery. 'Minimally invasive' means the surgeons try to make smaller cuts.

What kind of tests will I have?

You'll have physical tests to measure the strength and movement of your arm and shoulder. You'll also be asked to complete questionnaires about how you're feeling and how the surgery affects your daily activities.

How long will I be in the study?

You'll be in the study for about 12 months after your breast reconstruction surgery. You'll have appointments before surgery, and then at 3, 6, and 12 months afterwards.

Do I need to live in France to participate?

The study mentions a requirement for a good understanding of the French language, suggesting it is taking place in a French-speaking region. You should ask your doctor about the specific location.

Will my regular medical care be affected if I join?

No, your decision to join or not join this study will not affect your usual medical care or treatment in any way.