Your session is about to expire
← Back to Search
Other
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 belowSelect...
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:Select...
I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
Select...
I am not pregnant or breastfeeding.
Select...
I am not on medications that affect my thinking, like those for sleep or pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at day 57
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 57
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 moreAwards & 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
74 Previous Clinical Trials
138,089 Total Patients Enrolled
43 Trials studying Breast Cancer
130,689 Patients Enrolled for Breast Cancer
Jonsson Comprehensive Cancer CenterLead Sponsor
370 Previous Clinical Trials
35,103 Total Patients Enrolled
24 Trials studying Breast Cancer
1,752 Patients Enrolled for Breast Cancer
Patricia A GanzPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
1 Previous Clinical Trials
5 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I was diagnosed with early stage breast cancer, finished initial treatments over a year ago, but it's been less than 5 years since my diagnosis.I have a serious health or mental condition that could affect my participation in the study.You have had allergic reactions to substances similar to oxaloacetate.I don't have active breast cancer or any serious chronic illness.I agree to use birth control during the study if I can become pregnant.I am not pregnant or breastfeeding.I am not on medications that affect my thinking, like those for sleep or pain.You have reported significant problems with your memory and thinking skills, as measured by a specific test.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive care (anhydrous enol-oxaloacetate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.