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Peer-reviewedCC BY-NC-NDJCO oncology advances

Results from a Phase II Single Arm Trial Evaluating the Safety and Efficacy of Anhydrous Enol-Oxaloacetate on Improving Cognitive Complaints in Breast Cancer Survivors

  • Patricia A. Ganz1,2,3
  • Kathleen Van Dyk3,4,5
  • Catherine M. Crespi3,6
  • Laura Petersen3
  • Mina S. Sedrak1,3
  • Julienne E. Bower3,4,7
7 affiliations
  1. 1Department of Medicine (Hematology-Oncology), David Geffen School of Medicine at UCLA, Los Angeles, CA
  2. 2Department of Health Policy & Management, UCLA Fielding School of Public Health, Los Angeles, CA
  3. 3UCLA Health Jonsson Comprehensive Cancer Center, Los Angeles, CA
  4. 4Semel Institute for Neuroscience and Human Behavior, Department of Psychiatry & Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA
  5. 5City of Hope Comprehensive Cancer Center, Duarte, CA
  6. 6Department of Biostatistics Department, UCLA Fielding School of Public Health, Los Angeles, CA
  7. 7Department of Psychology, University of California, Los Angeles, Los Angeles, CA
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Abstract

Background: Cancer-related cognitive impairment (CRCI) affects a substantial proportion of breast cancer survivors (BCS) and effective pharmacologic interventions are lacking. Oxaloacetate (OAA), a naturally occurring metabolic intermediate with glutamate-scavenging, anti-inflammatory, and mitochondrial bioenergetic properties, was evaluated for its safety and preliminary efficacy in improving cognitive complaints in BCS with moderate to severe CRCI. Methods: We conducted a single-arm, phase II trial enrolling early-stage BCS who were 12 months to 5 years post-primary treatment and reported significant cognitive complaints on the PROMIS Cognitive Function questionnaire. Participants received oxaloacetate 500 mg orally twice daily for 8 weeks. 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, neuropsychological test performance, and safety. Simon's two-stage design with subsequent sequential monitoring was used. Results: <0.0001), with improvement from the impaired to the normative range. Statistically significant improvements were also observed in total fatigue (p<.0001), mental fatigue (p<.0001), and physical function (p=.0003), with a trend toward improvement in insomnia (p=.09). Neuropsychological testing showed improvements in executive function and processing speed. Oxaloacetate was generally well-tolerated; gastrointestinal symptoms were the most common adverse events, leading to treatment discontinuation in two participants. There were no serious adverse events. Conclusions: Oxaloacetate treatment led to significant improvements in perceived cognitive impairment, fatigue, and physical functioning among BCS with CRCI, with acceptable tolerability. These findings support further investigation in a randomized, placebo-controlled trial to confirm efficacy.

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Cite

BibTeXRIS
BibTeX
@article{ganz2026results,
  title = {{Results from a Phase II Single Arm Trial Evaluating the Safety and Efficacy of Anhydrous Enol-Oxaloacetate on Improving Cognitive Complaints in Breast Cancer Survivors}},
  author = {Patricia A. Ganz and Kathleen Van Dyk and Catherine M. Crespi and Laura Petersen and Mina S. Sedrak and Julienne E. Bower},
  journal = {JCO oncology advances},
  year = {2026},
  month = oct,
  doi = {10.1200/oa-26-00063},
  url = {https://doi.org/10.1200/oa-26-00063},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Results from a Phase II Single Arm Trial Evaluating the Safety and Efficacy of Anhydrous Enol-Oxaloacetate on Improving Cognitive Complaints in Breast Cancer Survivors
AU  - Patricia A. Ganz
AU  - Kathleen Van Dyk
AU  - Catherine M. Crespi
AU  - Laura Petersen
AU  - Mina S. Sedrak
AU  - Julienne E. Bower
PY  - 2026
DA  - 2026/10/20
JO  - JCO oncology advances
DO  - 10.1200/oa-26-00063
UR  - https://doi.org/10.1200/oa-26-00063
AB  - Background: Cancer-related cognitive impairment (CRCI) affects a substantial proportion of breast cancer survivors (BCS) and effective pharmacologic interventions are lacking. Oxaloacetate (OAA), a naturally occurring metabolic intermediate with glutamate-scavenging, anti-inflammatory, and mitochondrial bioenergetic properties, was evaluated for its safety and preliminary efficacy in improving cognitive complaints in BCS with moderate to severe CRCI. Methods: We conducted a single-arm, phase II trial enrolling early-stage BCS who were 12 months to 5 years post-primary treatment and reported significant cognitive complaints on the PROMIS Cognitive Function questionnaire. Participants received oxaloacetate 500 mg orally twice daily for 8 weeks. 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, neuropsychological test performance, and safety. Simon's two-stage design with subsequent sequential monitoring was used. Results: <0.0001), with improvement from the impaired to the normative range. Statistically significant improvements were also observed in total fatigue (p<.0001), mental fatigue (p<.0001), and physical function (p=.0003), with a trend toward improvement in insomnia (p=.09). Neuropsychological testing showed improvements in executive function and processing speed. Oxaloacetate was generally well-tolerated; gastrointestinal symptoms were the most common adverse events, leading to treatment discontinuation in two participants. There were no serious adverse events. Conclusions: Oxaloacetate treatment led to significant improvements in perceived cognitive impairment, fatigue, and physical functioning among BCS with CRCI, with acceptable tolerability. These findings support further investigation in a randomized, placebo-controlled trial to confirm efficacy.
SN  - 2994-9750
ER  -