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临床试验/NCT05122000
NCT05122000已完成不适用

How Integrity of the Connectome and Nutritional Status Change Brain Function in Breast Cancer Patients Undergoing Chemotherapy

Ohio State University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Evaluate feasibility through recruitment and retention

研究概览

简要总结

Up to 78% of women diagnosed with breast cancer experience impairments in their cognitive function (e.g., frequent forgetfulness, slow processing speeds, and difficulties in concentration, multitasking and/or word retrieval) in the course of cancer treatment. These cognitive impairments (CI) have negative effects on patients' social relationships, overall life satisfaction, and treatment adherence. Dietary intake may be an important factor in mitigating risk of CI that breast cancer patients experience. Several studies have suggested that dietary intake of specific nutrients and foods (e.g., carotenoids, B-vitamin, and omega-3 fatty acids rich foods) can be helpful to decrease the severity of cancer-related cognitive impairment (CRCI). High-quality dietary patterns can be also helpful to protect white matter volume and its integrity; damage to and changes in white matter contributes to CRCI. However, despite the high incidence of CRCI in breast cancer patients, very little is known about etiology of CRCI. Thus, the purpose of this observational study with cross-sectional design is to examine the relationships of diet with brain structural and functional outcomes of breast cancer patients. The study will aim to enroll 30 female postmenopausal breast cancer survivors (age 45-75) who have recently completed chemotherapy treatment within 3-12 months from study enrollment. Participants will complete study questionnaires online, and will have an in-person study visit to complete a functional magnetic resonance imagine (MRI) scan, cognitive testing, and blood sample collection via fingerstick and venous blood draw. It is expected that this study will advance the field's understanding and ability to early assess, manage, and prevent CRCI.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Stage I-III breast cancer diagnosis
  • Between 3-12 months post-treatment with anthracycline or taxane-based chemotherapy
  • Postmenopausal (at least 12 months without menses; OR on ovarian suppression medication; OR status post oophorectomy)
  • English speaking

排除标准

  • Women who have permanent ferromagnetic metal in the body, a pacemaker, or have severe claustrophobia
  • Women who are pregnant or breastfeeding
  • Diagnosis of dementia, psychosis, alcohol or substance use disorders
  • Concurrent other malignancy or metastatic malignancy of any kind
  • Unable to give informed consent.

结局指标

主要结局

Evaluate feasibility through recruitment and retention

时间窗: Two years

Retention is determined by numbers of participants who drop out from the study versus compared to those who complete the study.

次要结局

  • Assessment of Brain connectivity(one day)
  • Assessment of Diet Quality Measures(one day)
  • Assessment of cognition using the Oral Trail Making Test(One day)
  • Assessment of presence of CRCI symptoms(One day)
  • Assessment of cognition using the Hopkins Verbal Learning Test(One day)
  • Assessment of cognition using the WAIS-IV Digit Span(One day)
  • Assessment of cognition using the COWA Test(One day)
  • Assessment of cognition using the Boston Naming Test(One day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tonya Orchard

Associate Professor

Ohio State University

研究点 (1)

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