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

NCT04290897 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 19-001881NCI-2020-00676
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Early-Stage Breast Carcinoma; Prognostic Stage 0 Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

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

  Patients who have an improvement in the FACT-Cog PCI of at least 4 points will be considered to have a positive response. The response proportion will be further characterized using a point estimate and 95% exact binomial confidence interval.

  Baseline up to day 57

Secondary Outcomes (5)

• Incidence of adverse events

  Up to day 57

• Fatigue

  At day 57

• Insomnia

  At day 57

• Depressive symptoms

  At day 57

• Neurocognitive tests

  Up to day 57

Study Arms (1)

Supportive care (anhydrous enol-oxaloacetate)

EXPERIMENTAL

Patients receive anhydrous enol-oxaloacetate PO BID for 8 weeks in the absence of worsening symptoms or unacceptable toxicity.

Drug: Anhydrous Enol-oxaloacetate; Other: Questionnaire Administration

Interventions

Anhydrous Enol-oxaloacetate DRUG

Given PO

Supportive care (anhydrous enol-oxaloacetate)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (anhydrous enol-oxaloacetate)

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-Reported Outcomes Measurement Information System (PROMIS) Adult version (v) 2.0 - Cognitive Function 4a
• Is geographically accessible, and able to participate in a study of 8-10 weeks duration
• Ability to complete evaluation surveys in English
• The effects of oxaloacetate on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, 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
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Has another serious or chronic medical or psychiatric condition that contributes to substantial physical or emotional disability that would detract from participating in the planned study
• Taking chronic medications that would interfere with cognitive functioning such as medications for sleep, anxiety, narcotics for pain, use of illicit drugs or cannabis
• Participants may not be receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaloacetate
• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Breast Cancer Research Foundation: collaborator
• MetVital, Inc.: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Breast Carcinoma In Situ; Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Patricia A Ganz

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 2, 2020
• Study Start: September 29, 2021
• Primary Completion: November 12, 2024
• Study Completion: November 12, 2024
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

US (1)