Chemotherapy-Induced Cognitive Impairment in Patients With Ovarian Cancer: A Phase II Study of the Cognitive Effects of Platinum/Taxane-based Chemotherapy in Patients With Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Reliable Change Index (RCI)
研究概览
简要总结
Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a spectrum of neurocognitive deficits experienced during and after the administration of chemotherapy for cancer. The incidence of CICI is significant, affecting anywhere from 25 to 75% of survivors, and the biologic basis is unknown. This novel study is designed to address the questions of incidence and biological cause for CICI, while gaining a better understanding of the structural and functional effects of chemotherapy on the brain.
详细描述
Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a spectrum of neurocognitive deficits experienced during and after the administration of chemotherapy for cancer. The incidence of CICI is significant, affecting anywhere from 25 to 75% of survivors, and the biologic basis is unknown. This novel study is designed to address the questions of incidence and biological cause for CICI, while gaining a better understanding of the structural and functional effects of chemotherapy on the brain. In order to address these important objectives, a diverse team of experienced investigators has been assembled to design and implement the proposed protocol. The research team for this project seeks to accomplish the proposed objectives through following mechanisms: 1) assessment of the neurocognitive domains affected in CICI using a tailored battery of cognitive tests to define CICI; 2) measurement of serum markers of oxidative stress and correlation of these markers with neurocognitive test results; and 3) exploration of structural and functional changes in the brain during cognitive tasks and correlation of results with markers of oxidative stress and neurocognitive test results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with any stage epithelial ovarian cancer, including cancers arising from the fallopian tube and primary peritoneal cancer, or patients with other gynecologic malignancy (any stage), who are chemotherapy-naïve, and scheduled to undergo at least 6 cycles of intravenous platinum/taxane-based chemotherapy.
- •Patients must have adequate bone marrow, renal, hepatic, and sensory neurologic function to be eligible to receive platinum/taxane-based chemotherapy.
- •Patients must have a World Health Organization Performance Status of ≤
- •Age ≥18 years.
- •Ability to understand and the willingness to sign an approved written informed consent document.
排除标准
- •Patients who have received prior cytotoxic chemotherapy are ineligible. Patients may have received prior adjuvant hormonal therapy for localized breast cancer, provided that it was completed prior to registration, and that the patient remains free of recurrent or metastatic disease.
- •Patients undergoing neoadjuvant chemotherapy with planned interval cytoreductive surgery and adjuvant therapy are not included in this group.
- •Patients who are receiving any other investigational agents are excluded.
- •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic outcomes and other adverse events.
- •With the exception of non-melanoma skin cancer and other specific malignancies noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this therapy are excluded.
- •Patients with underlying dementia (or on medications to treat Alzheimer's disease such as donepezil, rivastigmine, galantamine, tacrine, or memantine), encephalopathy, or other neurological disorder known to adversely affect cognition (such as epilepsy or prior stroke) are excluded. (Patients with depression or anxiety are not excluded).
- •Patients will be excluded from fMRI testing if they are left-handed, claustrophobic, have a pacemaker, or have metal implants. Patients not undergoing fMRI testing may still enroll in clinical trial, including the ERP testing, if all other eligibility criteria are met.
- •Patients who are pregnant or nursing are excluded. Pregnant women are excluded from this study because cytotoxic chemotherapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cytotoxic chemotherapy, breastfeeding should be discontinued if the mother is treated with cytotoxic chemotherapy.
- •Patients who are non-English speaking are excluded because of the inability to adequately administer neurocognitive testing in non-English languages.
结局指标
主要结局
Reliable Change Index (RCI)
时间窗: 4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days)
To address the primary aim, RCI (which is essentially a z-score) for each patient will be calculated from the pre-, post-chemotherapy Montreal Cognitive Assessment (MoCA) test results. Then a Wilcoxon signed rank test will be applied to the RCI values with corresponding 95% confidence intervals.
次要结局
- Assess the correlation between biologic markers of oxidative stress and neurocognitive test results.(4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days))
- Assess the correlation between brain imaging and neurocognitive test results(4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days))
研究者
Rachel Miller
Principal Investigator
University of Kentucky