TOPLINE

Breast cancer survivors (BCSs) with moderate to severe cancer-related cognitive impairment (CRCI) who received oxaloacetate 500 mg twice daily for 8 weeks experienced clinically significant improvements in perceived cognitive function, with all evaluable participants showing improvement from impaired to normative range. Participants also reported substantial reductions in fatigue and improvements in physical functioning.

METHODOLOGY

• A single-arm, phase 2 trial enrolled 18 early-stage BCSs who were 12 months to 5 years post–primary treatment and reported significant cognitive complaints on the PROMIS Cognitive Function questionnaire (raw score <12).
• Participants received anhydrous enol-oxaloacetate 500 mg by mouth twice daily for 8 weeks; 16 of 18 participants completed the intervention.
• The primary endpoint was improvement in perceived cognitive impairment measured by the Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairment (FACT-Cog PCI) score.
• Secondary outcomes included fatigue, insomnia, psychological symptoms, physical and mental health–related quality of life, and neuropsychological test performance.
• Participants had a mean age of 49.6 years, 61% had received chemotherapy, and 89% were currently on endocrine therapy; the study was conducted in Los Angeles.

TAKEAWAY

• All 16 evaluable participants demonstrated clinically and statistically significant improvement in perceived cognitive impairment, with a mean FACT-Cog PCI change of 26.4 points (P < .0001), moving from a baseline mean score of 29.1 to 55.5.
• Statistically significant improvements were observed in total fatigue (P < .0001), mental fatigue (P < .0001), and physical function as measured by the SF-12 Physical Component Score (P = .0003).
• Neuropsychological testing revealed improvements in executive function and processing speed, including significant gains on the Delis Kaplan Executive Function System (DKEFS) Color Word Inhibition test (P < .01) and Inhibition/Switching test (P < .01).
• A trend toward improvement in insomnia was noted (P = .09), while mental health scores remained stable throughout the treatment period.

IN PRACTICE

"These findings support further investigation in a randomized placebo-controlled trial to confirm efficacy," wrote the authors of the study.

SOURCE

The study was led by Patricia A. Ganz, MD, UCLA Health Jonsson Comprehensive Cancer Center in Los Angeles. It was published online on October 20 in JCO Oncology Advances.

LIMITATIONS

The single-arm design without a placebo control limits interpretation of results, as placebo effects could not be ruled out. The small sample size of 18 participants (16 evaluable) restricts generalizability. Planned biomarker assessments of inflammation and mitochondrial function were only obtained in 5 participants, preventing meaningful evaluation of potential mechanisms.

DISCLOSURES

The study was supported by grants from the Breast Cancer Research Foundation and the Jonsson Comprehensive Cancer Center. The authors reported no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.