Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-00676 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19-001881 | Other Identifier | UCLA / Jonsson Comprehensive Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Breast Cancer Research Foundation | OTHER |
| MetVital, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
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.
PRIMARY OBJECTIVE:
I. 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:
I. 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anhydrous Enol-oxaloacetate | Drug | Given PO |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Will be assessed by Common Terminology Criteria for Adverse Events version 4. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patricia A Ganz | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Questionnaire Administration |
| Other |
Ancillary studies |
|
| 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. | 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. | 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. | Up to day 57 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 14, 2025 | Sep 2, 2025 | 15 |
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided