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 Journal Article
| Authors: | Nakamura, Z. M.; Deal, A. M.; Park, E. M.; Stanton, K. E.; Lopez, Y. E.; Quillen, L. J.; O’Hare Kelly, E.; Heiling, H. M.; Nyrop, K. A.; Ray, E. M.; Dees, E. C.; Reeder-Hayes, K. E.; Jolly, T. A.; Carey, L. A.; Abdou, Y.; Olajide, O. A.; Rauch, J. K.; Joseph, R.; Copeland, A.; McNamara, M. A.; Ahles, T. A.; Muss, H. B. |
| Article Title: | 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 |
| 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. © 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. |
| Keywords: | adult; controlled study; treatment outcome; middle aged; major clinical study; clinical trial; constipation; drug tolerability; fatigue; cancer combination chemotherapy; diarrhea; drug dose reduction; side effect; cancer staging; antineoplastic agent; treatment indication; quality of life; phase 2 clinical trial; breast cancer; mastectomy; peripheral neuropathy; clinical assessment; breast neoplasms; age; self report; dizziness; questionnaire; confusion; depression; feasibility study; feasibility studies; early cancer; prophylaxis; breast tumor; comorbidity; scoring system; anxiety disorder; cognition; cognitive defect; headache; neoadjuvant chemotherapy; drug dose titration; liver enzyme; neuropsychological assessment; sleep disorder; cytopenia; clinical trials; caucasian; lumpectomy; sample size; working memory; behavioral science; memantine; cognitive dysfunction; power analysis; visual memory; humans; human; male; female; article; cancer-related cognitive impairment; cognition assessment; preliminary data; program acceptability; disruptive behavior; brief medication questionnaire; delayed matching to sample test; objective cognitive domain composite measure |
| Journal Title: | Cancer Medicine |
| Volume: | 12 |
| Issue: | 7 |
| ISSN: | 2045-7634 |
| Publisher: | Wiley Blackwell |
| Date Published: | 2023-04-01 |
| Start Page: | 8172 |
| End Page: | 8183 |
| Language: | English |
| DOI: | 10.1002/cam4.5619 |
| PUBMED: | 36645168 |
| PROVIDER: | scopus |
| PMCID: | PMC10134315 |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PDF -- Source: Scopus |
