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治験 NCT06727773（対象：乳癌、局所進行乳癌、認知障害、認知機能低下、認知変化、乳癌ステージI、乳癌ステージII、乳癌ステージIII）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06727773 は 乳癌、局所進行乳癌、認知障害、認知機能低下、認知変化、乳癌ステージI、乳癌ステージII、乳癌ステージIII に関する 支持療法 の研究で、第II相・第二段階 介入研究 臨床試験 です。現在は 募集中 で、2025年5月7日 から開始しています。90 名の参加者 の募集が計画されています。この治験は UNC Lineberger Comprehensive Cancer Center によって主催され、2028年10月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月2日 です。
概要
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.
詳細説明
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.
公式タイトル
Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
疾患／病気
乳癌局所進行乳癌認知障害認知機能低下認知変化乳癌ステージI乳癌ステージII乳癌ステージIIIその他の研究識別子
- LCCC2425
- K23AG086604 (米国NIHの助成金/契約)
NCT番号
開始日
2025-05-07
最終更新日
2025-09-02
終了予定日
2028-10-31
目標参加者数
90
試験の種類
介入研究
治験の相・段階
第II相・第二段階
状況
募集中
キーワード
chemotherapy
memantine
placebo-controlled
exercise
Get Real & Heel cancer exercise program
memantine
placebo-controlled
exercise
Get Real & Heel cancer exercise program
主目的
支持療法
割付方法
無作為化
介入モデル
並行割当
盲検化
三重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Arm 1 Participants will receive study medication (memantine) and Get Real \& Heel exercise guided by the therapist. | Memantine memantine capsule 運動介入 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. |
プラセボ対照薬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. |
実験的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. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
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)試験中央連絡先
連絡先: Ashley M Hanson, +1 984-888-9244, [email protected]
1 1カ国の場所
North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, 27599, United States
Zev M Nakamura, MD, 連絡先, [email protected]
Zev M Nakamura, MD, 研究責任者
募集中