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Oxaloacetate for Cognitive Function in Breast Cancer Survivors

Q: What are some of the dangers that Anhydrous Enol-oxaloacetate poses to patients?

This clinical trial is still in its early stages, so not much is known about the safety of Anhydrous Enol-oxaloacetate. However, data collected so far suggests that it is safe to use, and it received a score of 2.

Q: Does this research project allow patients that are above the age of 60 to enroll?

This particular study is only enrolling patients aged 18-74. However, there are 65 trials specifically designed for children and 2290 clinical trials that cater to adults over the age of 65.

Q: Are there any available spots left for participants in this experiment?

Yes, this study is still recruiting participants. The listing on clinicaltrials.gov shows that the trial was posted on 9/29/2021 and updated as recently as 3/17/2022.

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

Women of childbearing potential must agree to use adequate contraception (barrier method of birth control; intrauterine device [IUD]; abstinence) prior to study entry and for the duration of study participation. Women of any age who have had their ovaries and/or uterus removed will not be at risk for pregnancy and will not require contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. Menopausal status will be established as follows: Women who are 55 years or older and who are not menstruating will be considered postmenopausal and not at risk for pregnancy. Women who are less than 55 years old who are menstruating will be considered premenopausal and will require contraception. Women who are less than 55 years with an intact uterus and ovaries who are not menstruating and have not had a menstrual period within the past 2 years will have an follicle-stimulating hormone (FSH) and estradiol measured. If the values are in postmenopausal range the woman will be considered postmenopausal and she will not be considered at risk for pregnancy

Women with a diagnosis of early stage breast cancer (stage 0, I, II, IIIa) who are at least 12 months after surgery, chemotherapy, radiation, but may be on endocrine therapy or HER-2 targeted therapy, and not more than 5 years after their breast cancer diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 57

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I agree to use birth control during the study if I can become pregnant.

Select...

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.

Select...

I don't have active breast cancer or any serious chronic illness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 57

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairment (FACT-Cog PCI) score

Secondary outcome measures

Depressive Symptoms

Fatigue

Incidence of adverse events

+2 more

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.

0 / 3Eligibility criteria met

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

69 Previous Clinical Trials

137,779 Total Patients Enrolled

42 Trials studying Breast Cancer

130,513 Patients Enrolled for Breast Cancer

Jonsson Comprehensive Cancer CenterLead Sponsor

359 Previous Clinical Trials

26,051 Total Patients Enrolled

24 Trials studying Breast Cancer

1,758 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are a part of this clinical study?

"From what is published on clinicaltrials.gov, it seems that this trial is still recruiting patients. The listing shows that the trial was first posted on September 29th 2021 and was last edited March 17th 2022. They are looking for a total of 24 participants at a single site."

Answered by AI

To whom is this research available?

"This study is looking for 24 participants who are currently breast cancer patients and fall within the ages of 18-74. Additionally, it is important that patients meet the following criteria: Women with a diagnosis of early stage breast cancer (stage 0, I, II, IIIa) who are at least 12 months after surgery, chemotherapy, radiation, but may be on endocrine therapy or HER-2 targeted therapy, and not more than 5 years after their breast cancer diagnosis; No evidence of active/recurrent breast cancer or other serious chronic illness; Has significant cognitive complaints, defined as a score of < 12 on the Patient-Rep"

Answered by AI

What are some of the dangers that Anhydrous Enol-oxaloacetate poses to patients?

"This clinical trial is still in its early stages, so not much is known about the safety of Anhydrous Enol-oxaloacetate. However, data collected so far suggests that it is safe to use, and it received a score of 2."

Answered by AI

Does this research project allow patients that are above the age of 60 to enroll?

"This particular study is only enrolling patients aged 18-74. However, there are 65 trials specifically designed for children and 2290 clinical trials that cater to adults over the age of 65."

Answered by AI

Are there any available spots left for participants in this experiment?

"Yes, this study is still recruiting participants. The listing on clinicaltrials.gov shows that the trial was posted on 9/29/2021 and updated as recently as 3/17/2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oxaloacetate for the Improvement of Cognitive Complaints in Stage 0-IIIA Breast Cancer Survivors

2021. "Oxaloacetate for the Improvement of Cognitive Complaints in Stage 0-IIIA Breast Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04290897.

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