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A Study of Oxytocin Nasal Spray to Reduce Psychological Stress in Women Who Have Recovered from Breast Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals who have survived breast cancer and examines how oxytocin nasal spray might help reduce stress levels after cancer treatment. Oxytocin is a naturally occurring hormone in the body that may have stress-reducing properties. The study will evaluate whether this treatment can help improve emotional well-being in people who have completed their cancer therapy.

During the study, participants will receive either oxytocin nasal spray or a placebo nasal spray containing salt water. The treatment will be given through the nose for up to 5 days. Throughout the study period, participants will complete various questionnaires about their stress levels, emotional state, sleep quality, and thinking abilities. They will also perform some computer-based tasks to assess their cognitive function.

The study aims to understand if using oxytocin nasal spray can help reduce psychological distress that many people experience after breast cancer treatment. The research will measure changes in stress levels, anxiety, depression, and overall quality of life to determine if this treatment approach could be beneficial for breast cancer survivors.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and medication start

    You will begin using nasal spray medication. The spray will contain either oxytocin or a placebo (salt water solution).

    The nasal spray should be administered according to the prescribed schedule provided by your healthcare provider.

  2. Step 2

    Primary evaluation measures

    You will complete two questionnaires to assess emotional well-being:

    The Perceived Stress Scale (PSS) to measure your stress levels

    The Depression Anxiety Stress Scale (DASS-42) to evaluate mood and anxiety

  3. Step 3

    Additional assessments

    You will complete several questionnaires to evaluate:

    Cognitive function using the Cognitive Failure Questionnaire

    Energy levels using the Checklist Individual Strength

    Quality of life using the WHO-5 questionnaire

    Relationship patterns using the State Adult Attachment Measure

    Sleep quality using the Pittsburgh Sleep Quality Index

    Thought patterns using the Perseverative Thinking Questionnaire

    Your own assessment of improvement using a clinical impression scale

  4. Step 4

    Cognitive performance testing

    You will complete the Amsterdam Cognition Scan, a digital test to measure cognitive performance

  5. Step 5

    Study duration

    The study period runs from October 2025 to October 2027

    Your individual participation duration will be specified in your personal schedule

Who can join the trial?

6 criteria

  • You must provide voluntary written consent before any screening procedures can begin
  • You must be between 18 and 65 years old when signing the consent form
  • You must be a person with female biological sex
  • You must have been diagnosed with breast cancer (with or without single metastasis, except brain metastasis). Metastasis means cancer that has spread from its original location to another part of the body
  • You must have completed chemotherapy and/or radiotherapy between 6 months to 6 years before joining the study. You can participate if you are currently receiving ongoing hormone therapy (endocrine therapy) or immunotherapy
  • You must be able to speak and understand Dutch language well enough to complete study tasks, but you don't need to be a native speaker

Who cannot join the trial?

13 criteria

  • Current age below 18 years or above 65 years
  • Male gender (only females can participate)
  • Currently undergoing active cancer treatment (such as chemotherapy or radiation)
  • History of other types of cancer besides breast cancer
  • Presence of severe psychiatric conditions (serious mental health disorders that require ongoing treatment)
  • Current use of medications that could interact with oxytocin (the study medication)
  • Pregnancy or breastfeeding
  • Uncontrolled high blood pressure or heart conditions
  • History of adverse reactions to oxytocin or similar medications
  • Participation in other clinical trials within the past 30 days
  • Inability to provide informed consent
  • Substance abuse or dependence within the past 6 months
  • Presence of any condition that could interfere with the study procedures or results
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Investigated drugs

Oxytocin is a hormone that naturally occurs in the human body and can also be given as a medication. It plays an important role in social bonding, stress reduction, and emotional well-being. In this trial, it is being studied for its potential to help breast cancer survivors manage psychological stress and reduce emotional distress. The medication may help improve stress regulation and overall psychological well-being in patients who have completed breast cancer treatment.

What is already known about the treatment

Oxytocin – A naturally occurring hormone and medication that can be administered as a nasal spray or through injection, commonly known as the "bonding hormone." In this clinical trial, it is being studied for its potential stress-reducing effects in breast cancer survivors, representing a novel therapeutic approach beyond its traditional uses in childbirth and social bonding. The medication works by binding to oxytocin receptors in the brain, influencing emotional processing, stress response, and social behavior through complex neurological pathways. Belonging to the class of peptide hormones, oxytocin is being investigated for its ability to modulate psychological distress and improve emotional well-being in cancer survivors, marking an innovative expansion of its therapeutic applications.

Investigated diseases

Breast Cancer – A disease that begins when cells in the breast start to grow out of control and form abnormal tissue. These cancer cells typically form a tumor that can often be seen on an x-ray or felt as a lump. The disease usually starts in either the ducts that carry milk to the nipple or the glands that make breast milk. Breast cancer can spread when the cancer cells get into the blood or lymph system and are carried to other parts of the body. The disease can affect both women and men, though it's much more common in women. The growth rate and pattern of the disease can vary significantly between individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519383-40-00Estimated enrolment60 patientsSponsorUZ Leuven

sourced from the EU Clinical Trials Register and site verification

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