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Oxaloacetate for Cognitive Function in Breast Cancer Survivors

Phase 2
Recruiting
Led By Patricia A Ganz
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No evidence of active/recurrent breast cancer or other serious chronic illness
Be older than 18 years old
Must not have
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or breast-feeding women are excluded from this study because the safety of oxaloacetate in this setting is unknown. A pregnancy test will be performed on all women with an intact uterus and ovaries who are not determined to be postmenopausal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 57
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether oxaloacetate, a natural substance found in the body, can help reduce cognitive complaints in breast cancer survivors.

Who is the study for?
This trial is for women who've had early-stage breast cancer (stage 0-IIIa), are 12+ months post-treatment but within 5 years of diagnosis, and have cognitive complaints. They must be able to complete surveys in English, sign consent, use contraception if necessary, and not have active cancer or serious illnesses.
What is being tested?
The study tests oxaloacetate's effectiveness in reducing cognitive issues after breast cancer treatment. Participants will take this natural supplement over an 8-10 week period and answer questionnaires to assess changes in their cognitive function.
What are the potential side effects?
Since oxaloacetate is a naturally occurring substance and used as a nutritional supplement, it may be well tolerated with minimal side effects; however, specific side effect profiles will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I don't have active breast cancer or any serious chronic illness.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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I am not pregnant or breastfeeding.
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I am not on medications that affect my thinking, like those for sleep or pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 57
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 57 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairment (FACT-Cog PCI) score
Secondary study objectives
Depressive Symptoms
Fatigue
Incidence of adverse events
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive care (anhydrous enol-oxaloacetate)Experimental Treatment2 Interventions
Patients receive anhydrous enol-oxaloacetate PO BID for 8 weeks in the absence of worsening symptoms or unacceptable toxicity.

Find a Location

Who is running the clinical trial?

MetVital, Inc.Industry Sponsor
1 Previous Clinical Trials
80 Total Patients Enrolled
Breast Cancer Research FoundationOTHER
72 Previous Clinical Trials
137,879 Total Patients Enrolled
42 Trials studying Breast Cancer
130,509 Patients Enrolled for Breast Cancer
Jonsson Comprehensive Cancer CenterLead Sponsor
370 Previous Clinical Trials
35,170 Total Patients Enrolled
24 Trials studying Breast Cancer
1,752 Patients Enrolled for Breast Cancer

Media Library

Anhydrous Enol-oxaloacetate (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04290897 — Phase 2
Breast Cancer Research Study Groups: Supportive care (anhydrous enol-oxaloacetate)
Breast Cancer Clinical Trial 2023: Anhydrous Enol-oxaloacetate Highlights & Side Effects. Trial Name: NCT04290897 — Phase 2
Anhydrous Enol-oxaloacetate (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04290897 — Phase 2
~5 spots leftby Nov 2025
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