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

Nakamura, Zev M.; Deal, Allison M.; Park, Eliza M.; Stanton, Kate E; Lopez, Yesy; Quillen, Laura J.; Kelly, Erin O'Hare; Heiling, Hillary; Nyrop, Kirsten A.; Ray, Emily; Dees, Elizabeth Claire; Reeder‐Hayes, Katherine E.; Jolly, Trevor A.; Carey, Lisa A.; Abdou, Yara; Olajide, Oludamilola; Rauch, Julia K; Joseph, Ranjit; Copeland, Anureet; McNamara, Megan Ann; Ahles, Tim A.; Muss, Hyman B.

doi:10.1002/cam4.5619

Cited by 8 publications

(3 citation statements)

References 65 publications

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“…We found only a phase II single-arm study of memantine administered concurrently with adjuvant chemotherapy to patients with breast cancer, in which approximately 90% of women showed stable or improved cognitive function at 4 weeks after chemotherapy treatment. 39 The absence of a control group, however, makes interpretation of these findings difficult.…”

Section: Discussionmentioning

confidence: 99%

Phase III Randomized, Placebo-Controlled Clinical Trial of Donepezil for Treatment of Cognitive Impairment in Breast Cancer Survivors After Adjuvant Chemotherapy (WF-97116)

Rapp,

Dressler,

Brown

et al. 2024

JCO

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PURPOSE To test efficacy of donepezil, a cognitive enhancer, to improve memory in breast cancer survivors who report cancer-related cognitive impairment 1-5 years postchemotherapy. PATIENTS AND METHODS Adult female BCS exposed to ≥4 cycles of adjuvant chemotherapy 1-5 years before enrollment who reported cancer-related cognitive impairment were eligible. Participants, enrolled at sites affiliated with the Wake Forest NCI Community Oncology Research Program (NCORP) Research Base, were randomly assigned to receive 5 mg of donepezil once daily for 6 weeks titrated to 10 mg once daily for 18 weeks or placebo. Cognition and self-report cognitive functioning was assessed at baseline, 12, 24 (end of intervention), and 36 (washout) weeks postrandomization. Mixed-effects repeated measures analysis of covariance models were used to assess treatment differences in immediate recall (primary outcome) on the Hopkins Verbal Learning Test-Revised (HVLT-R) and other cognitive domains (secondary outcomes) with covariates of treatment, time, time by treatment interaction, baseline outcome level, age stratification, and an unstructured covariance matrix to account for within participant correlation over time. RESULTS Two hundred seventy-six BCS from 87 NCORP practices (mean age, 57.1, standard deviation [SD], 10.5) who were at a mean of 29.6 months (SD, 14.2) postchemotherapy were randomly assigned to donepezil (n = 140) or placebo (n = 136). At 24 weeks, treatment groups did not differ on HVLT-R scores (donepezil mean = 25.98, placebo = 26.50, P = .32). There were no statistically significant differences between treatments at 12, 24, or 36 weeks for attention, executive function, verbal fluency, processing speed, or self-reported cognitive functioning. Endocrine therapy and menopausal status did not affect results. CONCLUSION BCS 1-5 years after completing chemotherapy with documented memory problems, randomly assigned to 24 weeks of 5-10 mg of donepezil once daily, did not perform differently at the end of treatment on tests of memory, other cognitive functions, or subjective functioning than those randomly assigned to placebo.

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Section: Discussionmentioning

confidence: 99%

Phase III Randomized, Placebo-Controlled Clinical Trial of Donepezil for Treatment of Cognitive Impairment in Breast Cancer Survivors After Adjuvant Chemotherapy (WF-97116)

Rapp,

Dressler,

Brown

et al. 2024

JCO

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“…More importantly, drug repurposing offers shorter routes to the clinic to address diseases with unmet needs that require effective treatment. A number of potential agents that are approved for other indications, such as riluzole [ 29 ] for amyotrophic lateral sclerosis (based on its potential action to augment brain-derived neurotrophic factor (BDNF)) and memantine [ 30 ] for dementia (based on modulation of neuroinflammation), are potential approved medications that could be useful to repurpose for CRCI after thorough investigation. However, repurposing of existing drugs may not necessarily be the final solution to finding the cure for CRCI.…”

Section: Discussionmentioning

confidence: 99%

Research Attitude and Interest among Cancer Survivors with or without Cognitive Impairment

Chan

Acharya

et al. 2023

Cancers

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Background: We examined the research attitudes and willingness to participate in clinical research among cancer survivors with varying degrees of cognitive function. Methods: This is a secondary analysis of data collected through the University of California Irvine Consent-to-Contact registry. Cancer survivors completed the Cognitive Function Instrument (CFI), the Research Attitudes Questionnaire (RAQ), and willingness to participate (WTP) in certain research procedures. Perceived cognitive impairment (CI) was defined as the worst 20% CFI scores. Results: Here, 265 CI and 909 cognitively non-impaired (CNI) participants’ data were analyzed. Mean age and sex distribution were similar, with fewer non-Hispanic Whites and education years among CI participants. More CI participants self-reported past diagnoses of Alzheimer’s disease, mild cognitive impairment, stroke, depression, post-traumatic stress disorder, and alcohol abuse (all p < 0.05). CI participants were significantly more interested in studies investigating approved medications (92% vs. 87%, p = 0.030), lumbar puncture (47% vs. 38%, p = 0.027), and autopsy (78% vs. 69%, p = 0.022). After removing survivors with co-existing neuropsychiatric conditions, interest in autopsy studies remained statistically higher among CI (79% vs. 69%, p = 0.022). Conclusions: Participants with cancer and CI are open to research procedures and interventions that are traditionally less utilized, which may facilitate the discovery of the pathogenesis and interventions for cancer-related cognitive impairment (CRCI).

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“…While no established strategies exist for preventing cognitive dysfunction, recent research has suggested the potential benefits of medications like memantine and probiotic supplements. 15 , 16 A longitudinal study examining prechemotherapy diets proposed that consuming more monounsaturated fat and less saturated fat might protect against cognitive decline. 17 Additionally, a study protocol was published aiming to investigate the effects of exercise interventions.…”

Section: Preventionmentioning

confidence: 99%

Chemotherapy-related cognitive impairment: What we need to know and what we can do

Miyashita

2024

Asia-Pacific Journal of Oncology Nursing

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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: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Cited by 8 publications

References 65 publications

Phase III Randomized, Placebo-Controlled Clinical Trial of Donepezil for Treatment of Cognitive Impairment in Breast Cancer Survivors After Adjuvant Chemotherapy (WF-97116)

Phase III Randomized, Placebo-Controlled Clinical Trial of Donepezil for Treatment of Cognitive Impairment in Breast Cancer Survivors After Adjuvant Chemotherapy (WF-97116)

Research Attitude and Interest among Cancer Survivors with or without Cognitive Impairment

Chemotherapy-related cognitive impairment: What we need to know and what we can do

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