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临床试验 NCT06727773 针对乳腺癌，局部晚期乳腺癌，认知障碍，认知下降，认知变化，乳腺癌I期，乳腺癌II期，乳腺癌III期目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
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临床试验NCT06727773旨在研究支持治疗，主要针对乳腺癌，局部晚期乳腺癌，认知障碍，认知下降，认知变化，乳腺癌I期，乳腺癌II期，乳腺癌III期。这是一项II期 (第二期) 干预性研究试验，目前试验状态为招募中。试验始于2025年5月7日，计划招募90名患者。该研究由UNC Lineberger Comprehensive Cancer Center主导，预计于2028年10月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年9月2日。
简要概括
This randomized, placebo-controlled trial aims to assess the feasibility, acceptability, and preliminary efficacy of memantine and the University of Carolina (UNC)'s Get Real & Heel cancer exercise program (MEM+EX) in addressing cancer-related cognitive impairment (CRCI) and underlying CRCI biomarkers. Ninety stage I-III breast cancer patients with mild cognitive difficulties during chemotherapy will be randomized into three groups: MEM+EX, memantine, or placebo. The study will evaluate recruitment, retention, adherence, acceptability, cognitive function, brain-derived neurotrophic factor (BDNF), inflammatory markers, and frailty at multiple time points.
详细描述
There are 4 million breast cancer survivors in the U.S. and an estimated 1.4 million suffer from long-term cognitive deficits from cancer treatment. Compared to other cancers and treatments, cognitive decline has been most robustly described in breast cancer and following chemotherapy with up to 75% self-reporting and ~50% objectively demonstrating at least mild cognitive deficits after chemotherapy. Memantine, an N-methyl-D-aspartate receptor antagonist, is a promising medication to address underlying mechanisms of CRCI, including inflammation and pathways involving brain-derived neurotrophic factor (BDNF). Exercise, a promising intervention for frailty which intervenes on multiple mechanisms of aging, is an ideal strategy to augment the targeted effects of memantine.
The primary objective of this study is to demonstrate the feasibility and acceptability of MEM+EX during breast cancer chemotherapy. Secondarily, the preliminary efficacy of MEM+EX and memantine on putative biomarkers of CRCI and cognitive function will be evaluated. Furthermore, the impact of frailty on the preliminary efficacy of MEM+EX and memantine will be explored.
The proposed study has the potential to produce significant public health benefit by filling a major gap in effective CRCI treatments. It will provide important pilot data for future, definitive randomized controlled studies. Finally, this study will advance understanding of potential targets to pursue in future cognitive interventions, including pathways involving BDNF and inflammation, during treatment for cancer.
官方标题
Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
疾病
乳腺癌局部晚期乳腺癌认知障碍认知下降认知变化乳腺癌I期乳腺癌II期乳腺癌III期其他研究标识符
- LCCC2425
- K23AG086604 (美国 NIH 拨款/合同)
NCT编号
实际开始日期
2025-05-07
最近更新发布
2025-09-02
预计完成日期
2028-10-31
计划入组人数
90
研究类型
干预性研究
试验分期 (阶段)
II期 (第二期)
试验状态
招募中
关键词
chemotherapy
memantine
placebo-controlled
exercise
Get Real & Heel cancer exercise program
memantine
placebo-controlled
exercise
Get Real & Heel cancer exercise program
主要目的
支持治疗
分配方式
随机
干预模型
平行
盲法
三盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Arm 1 Participants will receive study medication (memantine) and Get Real \& Heel exercise guided by the therapist. | Memantine memantine capsule 运动干预 Exercise Intervention participants will concurrently engage in remotely delivered Get Real \& Heel, 3d/week. Intensity for aerobic and strength-training components will progress as tolerated under the direction of a trained exercise physiologist. |
安慰剂对照Arm 2 Participants have access to a library of pre-recorded Get Real \& Heel sessions. | Placebo Medication placebo capsule Exercise Control Exercise control will have access to a library of pre-recorded Get Real \& Heel sessions. |
实验性Arm 3 Participants will receive study medication (memantine) and access to a library of pre-recorded Get Real \& Heel sessions. | Memantine memantine capsule Exercise Control Exercise control will have access to a library of pre-recorded Get Real \& Heel sessions. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Rates of recruitment | Rates of recruitment will be measured as a number of subjects joined the study. | Baseline |
Rates of retention | Rates of retention will be measured as the proportion of subjects who remained in the study at post-intervention (up to 6 months) and after 6 months among those who started the intervention | Up to a year |
Rates of adherence | Rates of adherence will be measured as a number of subjects who joined the study completed 80 percent of planned study activities. | Up to a year |
The acceptability of memantine + Get Real and Heel (MEM+EX) | The acceptability of memantine + Get Real and Heel (MEM+EX) will be assessed using the Client Satisfaction Questionnaire (CSQ-3). CSQ-3 is a three-item measure of treatment acceptability that has demonstrated excellent reliability and validity across a range of patient care settings.
Each item is scored on a Likert-type scale from 1 (low satisfaction) to 4 (high satisfaction). CSQ-3 will be completed at post-intervention only (or at the time of withdrawal from the study, if applicable). | Up to 6 months |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Attention and Executive Function Composite Score | The attention and executive function score is a composite of the following neuropsychological assessment measures: Digit Span, Trail Making Test Parts A\&B, Controlled Oral Word Association Test, and Animal Naming Test. It will be calculated as the sum of Z-scores (standardized based on available age-, sex-, education-, and race/ethnicity-matched normative data) of the individual subtests and range from a Z-score of -3 to +3. | Baseline and up to 1 year |
Learning and Memory Composite Score | The learning and memory score is a composite of the following neuropsychological assessment measures: Hopkins Verbal Learning Test-Revised and Brief Visual Memory Test-Revised. It will be calculated as the sum of Z-scores (standardized based on available age-, sex-, education-, and race/ethnicity-matched normative data) of the individual subtests and range from a Z-score of -3 to +3. | Baseline and up to 1 year |
Changes in patient-reported cognition | The impact of MEM+EX and memantine on cognitive function will be determined by examining changes in patient-reported cognition, as measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog PCI) version 3, compared to placebo.
FACT-Cog PCI is a self-report measure designed to assess perceived cognitive functioning in cancer patients, particularly those experiencing chemotherapy-induced cognitive problems. It consists of 18 items and each item is rated on a 5-point Likert scale, ranging from 0 (Never) to 4 (Several times a day). The total score is obtained by summing the subscale scores. Higher scores indicate better perceived cognitive functioning. | Baseline and up to 1 year |
The impact of MEM+EX and memantine on brain-derived neurotrophic factor (BDNF) | The impact of MEM+EX and memantine on putative biomarkers of CRCI will be determined by examining changes in BDNF compared to placebo. | Baseline and up to 6 months |
The impact of MEM+EX and memantine on inflammatory markers | The impact of MEM+EX and memantine on putative biomarkers of CRCI will be determined by examining changes in inflammatory composite measure (TNF-alpha, IL-6, CRP) compared to placebo. | Baseline and up to 6 months |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
女性
In order to participate in the study a subject must meet all of the eligibility criteria outlined below.
- Female
- Age ≥ 50 years at the time of consent.
- Stage I-III Breast Cancer
- Recommended chemotherapy
- Enroll prior to 3rd cycle of chemotherapy
- Completed at least 1 cycle of standard-of-care neoadjuvant or adjuvant chemotherapy
- At least mild self-reported cognitive concerns ≥3 on a 0-10 scale
- English-speaking
- Allergy to memantine
- Previous chemotherapy (prior to the current regimen),
- Severe cognitive impairment, defined by Blessed Orientation Memory Concentration Test Score ≥11
- Myocardial infarction in the last 6 months
- Cardiovascular or orthopedic limitations to exercise
- Severe mental illness (i.e., schizophrenia or bipolar affective disorder)
- Current alcohol or drug abuse
- Inability to swallow capsules </= 5mL/min
- CrCl </= 5mL/min
UNC Lineberger Comprehensive Cancer CenterNational Institute on Aging (NIA)研究中心联系人
联系人: Ashley M Hanson, +1 984-888-9244, [email protected]
1 位于 1 个国家/地区的研究中心
North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, 27599, United States
Zev M Nakamura, MD, 联系人, [email protected]
Zev M Nakamura, MD, 主要研究者
招募中