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Brief Title: Oxaloacetate for the Improvement of Cognitive Complaints in Stage 0-IIIA Breast Cancer Survivors
Official Title: A Phase II Single Arm Trial Evaluating the Safety and Efficacy of Anhydrous Enol-Oxaloacetate on Improving Cognitive Complaints in Breast Cancer Survivors
Study ID: NCT04290897
Brief Summary: This phase II trial studies how well oxaloacetate works in reducing cognitive complaints in stage 0-IIIA breast cancer survivors. Oxaloacetate is a natural substance found in the body and is available as a nutritional supplement. Giving oxaloacetate may reduce inflammation in the brain that could be contributing to cognitive complaints seen after cancer treatments.
Detailed Description: PRIMARY OBJECTIVE: I. To examine the effectiveness of anhydrous enol-oxaloacetate (oxaloacetate) in reducing cognitive complaints in breast cancer patients over the course of 8 weeks. SECONDARY OBJECTIVES: I. To assess the tolerability of oxaloacetate. II. To examine whether oxaloacetate has an effect on the neurocognitive domain of executive function. III. To examine whether oxaloacetate has an effect on patient reported fatigue, insomnia, and depressive symptoms. IV. To collect blood for assessment of inflammatory markers and glutamate levels. OUTLINE: Patients receive anhydrous enol-oxaloacetate orally (PO) twice daily (BID) for 8 weeks in the absence of worsening symptoms or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Name: Patricia A Ganz
Affiliation: UCLA / Jonsson Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR