Anatomic Stage 0 Breast Cancer AJCC v8Phase 2NCT04290897
Oxaloacetate for the Improvement of Cognitive Complaints in Stage 0-IIIA Breast Cancer Survivors
A Phase 2 study testing Anhydrous Enol-oxaloacetate and Questionnaire Administration in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women only
- Conditions the study is for
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
- What is being tested?
- Anhydrous Enol-oxaloacetate and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2021to 12 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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
- Being tested
- Anhydrous Enol-oxaloacetate, Questionnaire Administration
- Medical subject headings
- Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anhydrous Enol-oxaloacetateDrug
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Anhydrous Enol-oxaloacetate; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to day 57
Secondary outcomes (5)
Incidence of adverse events
Will be assessed by Common Terminology Criteria for Adverse Events version 4.
Measured: Up to day 57
Fatigue
Will be assessed by Multidimensional Fatigue Symptom Inventory. Scores will be summarized as means and standard deviations and confidence intervals will be calculated. Changes will also be summarized as effect sizes to support design of a future trial.
Measured: At day 57
Insomnia
Will be assessed by the Insomnia Severity Index. Scores will be summarized as means and standard deviations and confidence intervals will be calculated. Changes will also be summarized as effect sizes to support design of a future trial.
Measured: At day 57
Depressive symptoms
Will be assessed by Patient-Reported Outcomes Measurement Information System. Scores will be summarized as means and standard deviations and confidence intervals will be calculated. Changes will also be summarized as effect sizes to support design of a future trial.
Measured: At day 57
Neurocognitive tests
Subjects will be assessed by the California Verbal Learning Test-2nd edition, Brief Visuospatial Memory Test-Revised, Golden Stroop, Trail Making Test, Verbal Fluency, Connor's Continuous Performance Test-II. All scales listed will have the individual scores transformed by using published normative data, therefore the unit of measure will be the same for the listed tests; higher scores indicate better performance.
Measured: Up to day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start29 Sep 2021
- Primary completion12 Nov 2024
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage 0 Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation, MetVital, Inc.
- Responsible party
- Sponsor
- Investigators
- Patricia A Ganz, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290897
- Sponsor's protocol ID
- 19-001881
- Other IDs
- NCI-2020-00676, 19-001881
- Status last verified
- Jul 2025
- First submitted
- 25 Feb 2020
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04290897
- Acronym / sponsor ID
- 19-001881
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation, MetVital, Inc.
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (anhydrous enol-oxaloacetate) | Experimental | Drug: Anhydrous Enol-oxaloacetate, Other: Questionnaire AdministrationPatients receive anhydrous enol-oxaloacetate PO BID for 8 weeks in the absence of worsening symptoms or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anhydrous Enol-oxaloacetateGiven PO | Drug | Supportive care (anhydrous enol-oxaloacetate) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (anhydrous enol-oxaloacetate) |
Primary outcome
Change in Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairment (FACT-Cog PCI) score
Time frame: Baseline up to day 57
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.
5 secondary outcomes
Incidence of adverse events
Time frame: Up to day 57
Fatigue
Time frame: At day 57
Insomnia
Time frame: At day 57
Depressive symptoms
Time frame: At day 57
Neurocognitive tests
Time frame: Up to day 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia A Ganz principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anhydrous Enol-oxaloacetate and Questionnaire Administration in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairment (FACT-Cog PCI) score (time frame: Baseline up to day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.