RecruitingPHASE4INTERVENTIONAL

Dex & Mastectomy Pain

This study aims to understand if a common medication, dexamethasone, given during surgery for breast cancer (mastectomy), influences long-term pain. Many women experience ongoing pain after mastectomy, which can affect their daily lives. Dexamethasone is often used to prevent sickness after surgery and also has anti-inflammatory effects. We don't yet know if this medicine helps prevent long-term pain or if it could potentially contribute to it. This research will help doctors understand the best way to use this medication to support women recovering from mastectomy, by carefully studying its effects on pain three months after surgery.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrolment target

170

Start

13 Apr 2026

Estimated completion

30 Jun 2028

Post-Mastectomy Chronic Pain Syndrome

What is this study about?

Imagine recovering from surgery, and then months later, still feeling significant pain. This can happen after a mastectomy, which is surgery to remove a breast, often due to cancer. This ongoing pain can really impact a woman's everyday life and how she feels. Doctors and researchers are always looking for ways to prevent this long-term pain.

Now, there's a medicine called dexamethasone that is often given during surgery. It's really good at stopping you from feeling sick afterwards, but it also has effects on inflammation in the body. We know it helps with sickness, but we're not sure how it affects pain for months or even years after surgery. Some early studies have given mixed signals – some didn't see a clear link, while others in animals suggested it might even make pain sensitivity worse.

Because dexamethasone is used so frequently, it's really important to find out for sure what its long-term effects are on pain after mastectomy. This study is designed to give us clear answers by carefully comparing women who receive dexamethasone with those who receive a harmless liquid (placebo) during their surgery. We'll then check for pain three months later. The goal is to help doctors make the best choices about treatments during surgery to improve recovery and reduce long-term pain for women.

Key takeaways

This study investigates if a common anti-sickness drug given during mastectomy affects long-term pain.
It aims to understand if the drug helps prevent pain or could make it worse.
Participation involves receiving either the study drug or a harmless liquid during surgery.
You would be assessed for pain three months after your operation.
Joining helps doctors make better decisions for future patients having mastectomy.
You can stop taking part at any time without affecting your medical care.

Who may be eligible?

This study is looking for women aged 18 to 75 who are planning to have a mastectomy. This surgery can be on one or both breasts, and might include removing lymph nodes or immediate breast reconstruction. You would also need to be generally healthy enough for surgery, as determined by your doctors.

There are some reasons why you wouldn't be able to join. For example, if you're a man, or if you already have ongoing pain problems before your surgery, or if you're taking strong pain relief often. We also can't include women who are pregnant or breastfeeding, or who have had breast surgery very recently (within the last three years).

Finally, if you're already taking specific steroid medicines for a long time, or if there's any medical reason why you shouldn't have dexamethasone, then this study wouldn't be right for you. These rules help make sure the study is safe and that we can get clear results.

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 a woman aged between 18 and 75?
Are you having a mastectomy?
Do you currently have ongoing pain problems?
Are you pregnant or breastfeeding?
Have you had breast surgery in the last three years?
Are you regularly taking steroid medicines?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either the study drug (dexamethasone) or a harmless liquid (placebo) through a drip during your mastectomy. You wouldn't know which one you received, and neither would your doctors. After your surgery, your recovery would be followed as usual.

Precisely three months after your surgery, you would be asked to complete some questionnaires or have a short assessment to check for any ongoing pain. This might involve answering questions about how you feel and the intensity of any pain. There wouldn't be any extra hospital visits beyond your normal post-surgery check-ups unless specifically related to the study assessment at three months. The total duration of your active participation, for the purpose of the study's main outcome, would be limited to these three months following your operation.

Potential risks and benefits

Taking part in any study always involves carefully weighing the potential benefits and risks. A potential benefit of this study is helping to improve care for future patients by providing clear answers about how dexamethasone affects long-term pain. You might not directly benefit, but you'll be contributing to important medical knowledge. The potential risks associated with dexamethasone are generally well-known and for short-term use, it's often well-tolerated; however, all medicines have possible side effects, which your doctor will discuss with you. Receiving the placebo carries no direct drug-related risks. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

McGill University Health Centre (MUHC)
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is dexamethasone?

It's a common medicine often given during surgery to help prevent sickness and sometimes to reduce inflammation.

Why don't I know if I'm getting the drug or placebo?

This 'blinded' approach helps ensure the study results are as fair and unbiased as possible, so we can trust the findings.

What is 'chronic post-mastectomy pain'?

It's pain that continues for three months or more after a mastectomy, beyond the usual healing time.

Will taking part affect my usual cancer treatment?

No, this study is about a medication given during surgery and won't change your planned cancer treatment.

What's the main thing the study wants to find out?

It wants to know if dexamethasone given during mastectomy affects how much long-term pain women experience.

How to find out more

Oana Predescu, MD, PhD, MSc

oana.predescu@mcgill.ca 514-934-1934 Official trial record

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