AuthorisedTherapeutic confirmatory (Phase III)Interventional

Assessing Oxytocin's Role in Mitigating Psychosocial Stress in Breast Cancer Survivors

This study is exploring if a nasal spray containing oxytocin, a natural hormone, can help reduce feelings of stress, anxiety, and sadness in women who have survived breast cancer. Many women experience these challenges after treatment. The study will compare this oxytocin spray with a placebo, which is a dummy spray that looks and feels the same but contains no active medicine. Participants will answer questions about their feelings and well-being. The main goal is to see if oxytocin can make a significant difference in how stressed, anxious, and sad these women feel, ultimately aiming to improve their quality of life after breast cancer.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

UZ Leuven

Enrolment target

Start

19 Aug 2025

breast cancer

What is this study about?

This research study is looking into a topic that's really important for many women who have been through breast cancer. After fighting breast cancer, some women find it difficult to cope with emotional stress, anxiety, and sadness. This study wants to see if a natural hormone called oxytocin, given as a simple nasal spray, might help lessen these feelings. Oxytocin is sometimes called the 'love hormone' because it plays a role in social bonding and well-being.

The study will compare the oxytocin nasal spray with a 'dummy' spray, also known as a placebo. This placebo spray looks and feels exactly the same as the oxytocin spray but doesn't contain any active medicine. This allows the researchers to fairly check if any improvements are due to the oxytocin itself or just the general act of taking a spray. Everyone involved in the study will be asked to fill out questionnaires about their feelings of stress, anxiety, and general mental well-being to see if there's any difference between the groups.

The main aim of this study is to see if oxytocin can truly make a difference in how women who have had breast cancer experience stress, anxiety, and sadness. They will also look at other things like memory, how well people sleep, and overall quality of life. Finding ways to help women feel better emotionally after breast cancer treatment is a big goal, and this study hopes to provide some answers.

Key takeaways

The study explores if oxytocin nasal spray helps breast cancer survivors with stress and anxiety.
It compares oxytocin to a 'dummy' spray (placebo) to see if it really works.
Participants will answer questionnaires about their feelings and well-being.
The study aims to improve quality of life for women after breast cancer.
Participation involves using a nasal spray and completing surveys.

Who may be eligible?

To join this study, you need to be an adult woman, at least 18 years old. There's no upper age limit, meaning women of all adult ages can take part.

This study is specifically for women who have previously been diagnosed with and treated for breast cancer.

The researchers will need to check other details about your health to make sure the study is a good fit for you and safe. Only female participants are included.

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 an adult woman, aged 18 or older?
Have you been diagnosed with and treated for breast cancer?
Are you able to use a nasal spray?
Are you able to understand and answer questionnaires?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily be asked to use a nasal spray — either the oxytocin spray or the placebo (dummy) spray — for a certain period. You wouldn't know which one you are taking. You will also be asked to fill out several questionnaires at different times during the study. These questionnaires will ask about your feelings of stress, anxiety, sadness, quality of life, sleep, and how well you feel you're thinking. Additionally, you might complete some simple computer-based tests to check your memory and attention. The study team will explain how often you need to use the spray and how many times you will need to complete the assessments. They will also tell you about any follow-up appointments.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might feel better emotionally if the oxytocin spray works, but it's also possible you won't experience any changes, especially if you receive the placebo. At this stage, we don't fully know if oxytocin will help with stress in breast cancer survivors. The risks of using a nasal spray are generally low, but the study team will fully explain any known or potential mild side effects. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is oxytocin?

Oxytocin is a natural hormone in your body that's often linked to social bonding, trust, and feelings of well-being.

What is a 'placebo'?

A placebo is a 'dummy' treatment, like a nasal spray that looks and feels the same as the real one but contains no active medicine. It helps researchers fairly compare results.

Will I know if I'm getting the real spray or the dummy spray?

No, you won't know. This is a 'blinded' study so that your expectations don't affect the results. The researchers won't know either until the end of the study.

What kind of questions will I be asked?

You'll answer questions about how stressed, anxious, or sad you feel, your sleep, your general well-being, and how well you feel your memory is working.

Do I have to pay to join the study?

No, you will not have to pay to participate in the study.

How to find out more

Official trial record

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