Oxaloacetate for the Improvement of Cognitive Complaints in Stage 0-IIIA Breast Cancer Survivors
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage 0 Breast Cancer AJCC v8
- Anatomic Stage IA 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
- Anatomic Stage IB Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage IIIA 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 IIA Breast Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 74 years
- Gender
- Only males
Description
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 effe...
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.
Tracking Information
- NCT #
- NCT04290897
- Collaborators
- Breast Cancer Research Foundation
- MetVital, Inc.
- Investigators
- Principal Investigator: Patricia A Ganz UCLA / Jonsson Comprehensive Cancer Center
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