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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Phenomena and Processes [G] - Physiological processes [G07]

Decision date (initial)

2025-08-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To examine whether administration of oxytocin can induce stress-regulatory effects in breast cancer survivors. Primary objective: Change from baseline after oxytocin administration on self-reported clinical-behavioral outcomes of psychological distress.

Secondary objectives 2

1. Change from baseline after oxytocin administration on: • Self-reported clinical-behavioral outcomes (i.e. subjective cognitive complaints, quality of life, sleep quality, attachment, negative thinking) • Objective cognitive complaints
2. 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)

Conditions and MedDRA coding

breast cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
2. Participants must be between 18 and 65 years old at the time of signing the Informed Consent Form (ICF).
3. 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.
4. Participants have female biological sex.
5. Participants must have sufficient proficiency in Dutch to complete study tasks but do not need to be native speakers.

Exclusion criteria 8

1. Subjects who have had previous chronic treatment with oxytocin.
2. 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.
3. Being pregnant or breastfeeding, or planning to become pregnant.
4. Significant hearing or vision impairments (that cannot be corrected and that would interfere with the assessments).
5. Participation in another clinical trial with IMP (albeit not including clinical trials with endocrine therapy IMP).
6. Known hypersensitivity to active substance or ingredients in the nasal sprays, including e.g. (history of) latex allergy.
7. Use of the following medicinal products during the nasal spray administration period: prostaglandins and their analogues, inhalation anesthetics, vasoconstrictors/sympathomimetic drugs, or caudal anesthesia.
8. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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)

Secondary endpoints 2

1. 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).
2. Objective cognitive performance will be measured with the the digital Amsterdam Cognition Scan (ACS).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Kaat Alaerts

Public contact point

Organisation

UZ Leuven

Contact name

Kaat Alaerts

Third parties 2

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications