Oxytocin for Breast cancer | Psychological stress

Inclusion criteria

• {"criterion_text":"- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures."}
• {"criterion_text":"- Participants must be between 18 and 65 years old at the time of signing the Informed Consent Form (ICF)."}
• {"criterion_text":"- Participants are eligible if they were diagnosed with breast cancer with or without solitary metastases (except solitary brain metastases), received chemo- and/or radiotherapy in the context of breast cancer management and ended this treatment 6 months to 6 years before enrollment. Patients who receive prolonged endocrine therapy or immunotherapy are eligible for participation in this study."}
• {"criterion_text":"- Participants have female biological sex."}
• {"criterion_text":"- Participants must have sufficient proficiency in Dutch to complete study tasks but do not need to be native speakers."}

Exclusion criteria

• {"criterion_text":"- Subjects who have had previous chronic treatment with oxytocin."}
• {"criterion_text":"- Patient has a significant active medical condition including hematological, endocrine, cardiovascular (including any rhythm disorder), respiratory, renal, hepatic, or gastrointestinal disease which influence the metabolism of oxytocin (IMP). Participants with a history of active epilepsy, defined as individuals experiencing seizures or requiring anticonvulsant therapy within the past 12 months, will be excluded from the study."}
• {"criterion_text":"- Being pregnant or breastfeeding, or planning to become pregnant."}
• {"criterion_text":"- Significant hearing or vision impairments (that cannot be corrected and that would interfere with the assessments)."}
• {"criterion_text":"- Participation in another clinical trial with IMP (albeit not including clinical trials with endocrine therapy IMP)."}
• {"criterion_text":"- Known hypersensitivity to active substance or ingredients in the nasal sprays, including e.g. (history of) latex allergy."}
• {"criterion_text":"- Use of the following medicinal products during the nasal spray administration period: prostaglandins and their analogues, inhalation anesthetics, vasoconstrictors/sympathomimetic drugs, or caudal anesthesia."}
• {"criterion_text":"- Current treatment with abemaciclib or ribociclib constitutes an exclusion criterion due to the known risk of QTc prolongation and potential drug interactions. Treatment with tamoxifen is permitted, provided that a baseline ECG shows no QTc prolongation; patients with QTc prolongation while on tamoxifen are excluded."}

Primary endpoints

• {"endpoint_text":"- Assessments of self-perceived emotional stress, using the Dutch versions of the self-report Perceived stress scale (PSS) and the Depression Anxiety Stress Scale (DASS-42)","definition_or_measurement_approach":"Self-perceived emotional stress measured using Dutch versions of the Perceived Stress Scale (PSS) and the Depression Anxiety Stress Scale (DASS-42); change from baseline after oxytocin administration on self-reported clinical-behavioral outcomes of psychological distress."}

Secondary endpoints

• {"endpoint_text":"- Assessments of the following self-report questionnaires will be acquired as secondary end points: Cognitive Failure Questionnaire (CFQ), Checklist Individual Strength (CIS), Quality of Life (WHO-5), State Adult Attachment Measure (SAAM), Pittsburg Sleep quality index (PSQI), Perseverative Thinking Questionnaire (PTQ), and self-rated imression of severity and improvement (CGI).","definition_or_measurement_approach":"Collection of specified self-report questionnaires (CFQ, CIS, WHO-5, SAAM, PSQI, PTQ, CGI) as secondary outcome measures."}
• {"endpoint_text":"- Objective cognitive performance will be measured with the the digital Amsterdam Cognition Scan (ACS).","definition_or_measurement_approach":"Objective cognitive performance assessed using the digital Amsterdam Cognition Scan (ACS)."}

Other endpoints

• {"endpoint_text":"- The clinical trial also includes exploratory outcome measures examining treatment-mechanistic aspects of the oxytocin treatment: 1)Oxytocin hormonal levels. 2)Stress reactivity in daily life (experience sampling and ambulant physiology recording)","definition_or_measurement_approach":"Exploratory measures include oxytocin hormonal level measurements and assessment of stress reactivity in daily life using experience sampling and ambulatory physiology recording."}

Belgium

Earliest CTIS Part Ii Submission Date

07-08-2025

Latest Decision Or Authorization Date

19-08-2025

Processing Time Days

12

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"Netherlands","full_name":"Apotheek A15","duties_or_roles":"14","organisation_type":"Industry"}
• {"country":"Belgium","full_name":"Apotheek De Hallen","duties_or_roles":"14","organisation_type":"Health care"}