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Assessing Oxytocin's Role in Mitigating Psychosocial Stress in Breast Cancer Survivors
EU CTIS ID: 2024-519383-40-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Participants must be between 18 and 65 years old at the time of signing the Informed Consent Form (ICF).
- 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.
- Participants have female biological sex.
- Participants must have sufficient proficiency in Dutch to complete study tasks but do not need to be native speakers.
You likely can't join if
- Subjects who have had previous chronic treatment with oxytocin.
- 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.
- Being pregnant or breastfeeding, or planning to become pregnant.
- Significant hearing or vision impairments (that cannot be corrected and that would interfere with the assessments).
- Participation in another clinical trial with IMP (albeit not including clinical trials with endocrine therapy IMP).
- Known hypersensitivity to active substance or ingredients in the nasal sprays, including e.g. (history of) latex allergy.
See the full eligibility criteria
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Participants must be between 18 and 65 years old at the time of signing the Informed Consent Form (ICF).
- 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.
- Participants have female biological sex.
- Participants must have sufficient proficiency in Dutch to complete study tasks but do not need to be native speakers.
- Subjects who have had previous chronic treatment with oxytocin.
- 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.
- Being pregnant or breastfeeding, or planning to become pregnant.
- Significant hearing or vision impairments (that cannot be corrected and that would interfere with the assessments).
- Participation in another clinical trial with IMP (albeit not including clinical trials with endocrine therapy IMP).
- Known hypersensitivity to active substance or ingredients in the nasal sprays, including e.g. (history of) latex allergy.
- Use of the following medicinal products during the nasal spray administration period: prostaglandins and their analogues, inhalation anesthetics, vasoconstrictors/sympathomimetic drugs, or caudal anesthesia.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.