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Clinical Trial
. 2023 Apr;12(7):8172-8183.
doi: 10.1002/cam4.5619. Epub 2023 Jan 16.

A phase II single-arm trial of memantine for prevention of cognitive decline during chemotherapy in patients with early breast cancer: Feasibility, tolerability, acceptability, and preliminary effects

Zev M Nakamura  1   2 , Allison M Deal  2 , Eliza M Park  1   2   3 , Kate E Stanton  2 , Yesy E Lopez  1 , Laura J Quillen  1 , Erin O'Hare Kelly  2 , Hillary M Heiling  2 , Kirsten A Nyrop  2   3 , Emily M Ray  2   3 , E Claire Dees  2   3 , Katherine E Reeder-Hayes  2   3 , Trevor A Jolly  2   3 , Lisa A Carey  2   3 , Yara Abdou  2   3 , Oludamilola A Olajide  4 , Julia K Rauch  4 , Ranjit Joseph  4 , Anureet Copeland  4 , Megan A McNamara  4 , Tim A Ahles  5 , Hyman B Muss  2   3
Affiliations
Clinical Trial

A phase II single-arm trial of memantine for prevention of cognitive decline during chemotherapy in patients with early breast cancer: Feasibility, tolerability, acceptability, and preliminary effects

Zev M Nakamura et al. Cancer Med. 2023 Apr.

Abstract

Background: Cognitive difficulties have been described after chemotherapy for breast cancer, but there is no standard of care to improve cognitive outcomes in these patients. This trial examined the feasibility, tolerability, acceptability, and preliminary effects of memantine to prevent cognitive decline during chemotherapy for breast cancer.

Methods: Patients with stage I-III breast cancer, scheduled for neo/adjuvant chemotherapy, completed a cognitive battery prior to and 4 weeks after completing chemotherapy. Memantine (10 mg BID) was administered concurrent with chemotherapy. Our primary cognitive outcome was visual working memory assessed by the Delayed Matching to Sample test. We used the Brief Medication Questionnaire to assess acceptability.

Results: Of 126 patients approached, 56 (44%) enrolled. Forty-five (80%) received ≥1 dose of memantine and completed pre-post assessments. Seventy-six percent reported taking ≥90% of scheduled doses. Participants were mean age of 56, 77% White, and 57% had stage I disease. Sixty-four percent had stable or improved Delayed Matching to Sample test scores. Stable or improved cognition was observed in 87%-91% across objective cognitive domain composite measures. Sixty-six percent self-reported stable or improved cognitive symptoms. There were seven greater than or equal to grade 3 adverse events; two were possibly related to memantine. Only 5% reported that taking memantine was a disruption to their lives.

Conclusions: Memantine was well-tolerated and consistently taken by a large majority of patients receiving breast cancer chemotherapy. The majority demonstrated stable or improved cognition from pre- to post-assessment. Randomized trials are needed to determine memantine's efficacy to ameliorate cognitive loss.

Trial registration: ClinicalTrials.gov NCT04033419.

Keywords: behavioral science; breast cancer; cancer-related cognitive impairment; clinical trials; cognitive dysfunction; memantine; quality of life.

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Conflict of interest statement

Emily Ray receives research funding from OptumHealth and Pfizer. E. Claire Dees consults for Sanofi and receives research funding from Novartis, Genentech/Roche, Pfizer, Merck, H3 Biomedicine, and Meryx Pharmaceuticals. Katherine Reeder‐Hayes receives research funding from Pfizer. Lisa Carey receives research funding from Syndax, Novartis, NanoString Technologies, Abbvie, Seattle Genetics, and Veracyte. Yara Abdou consults for Exact Sciences.

Figures

FIGURE 1
FIGURE 1
Modified CONSORT flow diagram for a single‐arm trial of memantine to prevent cognitive decline during chemotherapy for early‐stage breast cancer.
FIGURE 2
FIGURE 2
Changes in severity of self‐reported cognitive difficulties from pre‐ to post‐assessment (N = 44).
See this image and copyright information in PMC

References

    1. Janelsins MC, Kesler SR, Ahles TA, Morrow GR. Prevalence, mechanisms, and management of cancer‐related cognitive impairment. Int Rev Psychiatry. 2014;26(1):102‐113. - PMC - PubMed
    1. Wefel JS, Kesler SR, Noll KR, Schagen SB. Clinical characteristics, pathophysiology, and management of noncentral nervous system cancer‐related cognitive impairment in adults. CA Cancer J Clin. 2015;65(2):123‐138. - PMC - PubMed
    1. Van Dyk K, Ganz PA. Cancer‐related cognitive impairment in patients with a history of breast cancer. JAMA. 2021;326(17):1736‐1737. - PubMed
    1. Ahles TA, Root JC. Cognitive effects of cancer and cancer treatments. Annu Rev Clin Psychol. 2018;14:425‐451. - PMC - PubMed
    1. Klaver KM, Duijts SFA, Engelhardt EG, et al. Cancer‐related cognitive problems at work: experiences of survivors and professionals. J Cancer Surviv. 2020;14:168‐178. - PMC - PubMed

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