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 study about?

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.

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 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 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 Cognitive performance testing

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	01.10.2025

Trial locations

Investigated drugs:

Oxytocin

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.

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 ID:

2024-519383-40-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?