A study looking at what happens in lymph nodes after a vaccine

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Other

This is a study to learn more about how the immune system responds to a vaccination.

Vaccinations Open a glossary item (or vaccines) can help to protect us from diseases. They can also be used to treat some types of cancer. A vaccine triggers an immune response Open a glossary item in the body.

More about this trial

Researchers want to learn more about how the body responds to vaccines. They often study blood samples to learn more about how your immune system responds. But in this study, they want to look at what happens in the lymph nodes Open a glossary item.

The people taking part in this study are having treatment for breast cancer. During surgery to remove breast cancer, the surgeon may remove a small number of lymph nodes from your armpit to see if they contain cancer cells. This is called a sentinel lymph node biopsy.

Some people taking part in this study have a vaccine before they have surgery. The vaccine is against a disease called tetanus. Everybody taking part has a sentinel lymph node biopsy as part of their planned treatment for breast cancer. The surgeon will remove 1 extra lymph node for the researchers to study.

The aim of the study is to learn more about how the body responds to the vaccine.

Who can enter

You may be able to enter this study if you

  • Are going to have a sentinel lymph node biopsy during surgery to remove breast cancer
  • Have not had a tetanus vaccination in the last 10 years
  • Are at least 18 years old

You cannot enter this study if you

  • Have breast cancer that has spread to another part of your body (metastatic breast cancer), or your doctors already know there is cancer in the lymph nodes under your arm
  • Take any medication that damps down your immune system such as steroids Open a glossary item (you can take part if you use a steroid inhaler)
  • Are known to be very sensitive to tetanus or hepatitis vaccines

Trial design

The study will recruit 60 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

  • 30 people will have a tetanus injection into the arm on the same side as they are having surgery – they have the injection just under the skin (subcutaneous injection)
  • 15 people will have a tetanus injection into the arm on the opposite side from their surgery – they have the injection into a muscle (intramuscular injection)
  • 15 people won’t have a tetanus injection

On the day you have surgery, your sentinel lymph nodes will be tested for cancer in the standard way. The researchers expect that about 9 out of 10 people won’t have any cancer cells in their lymph nodes. But if the tests show that any of your sentinel nodes do contain cancer, the extra lymph node that has been removed will not be used for this study.

As well as taking an extra lymph node when you have surgery, the researchers will take blood samples

  • Before your operation
  • When you have surgery
  • 2 weeks after surgery
  • 5 weeks after surgery

If your lymph node is found to contain cancer cells, you can either leave the study, or you can carry on and give the 2 further blood samples for research, even though your lymph node won’t be used.

Hospital visits

Taking part in the study means you have 1 extra hospital visit for the final blood test.

Side effects

If you have the tetanus injection into the muscle in the arm on the opposite side from your surgery, your arm may ache or feel sore.

If you have the injection into the arm on the same side as your surgery, you have it just under the skin (subcutaneous injection). This may cause more redness and tenderness than when you have an injection into a muscle.

Having an extra lymph node removed should not increase the risk of complications from surgery.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Mr Ramsey Cutress
Professor Christian Ottensmeier

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University Hospital Southampton NHS Foundation Trust
University of Southampton

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

9578

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Caroline took part in a clinical trial for breast cancer

“I had treatment last year and I want to give something back.”

Last reviewed:

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