2024-519383-40-00招募中3 期
Assessing Oxytocin's Role in Mitigating Psychosocial Stress in Breast Cancer Survivors
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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)
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)
次要结局
- 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).
- Objective cognitive performance will be measured with the the digital Amsterdam Cognition Scan (ACS).
研究者
Kaat Alaerts
Scientific
UZ Leuven
研究点 (1)
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