Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04290897

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

Anatomic Stage II Breast Cancer AJCC v8 Clinical Trial

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

Clinical 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. Giving oxaloacetate may reduce inflammation in the brain that could be contributing to cognitive complaints seen after cancer treatments.

Clinical Trial 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 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

Related Conditions & MeSH terms

  • 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
  • Breast Carcinoma In Situ
  • Breast Neoplasms
  • 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
Clinical Trial Details
NCT number NCT04290897
Study type Interventional
Source Jonsson Comprehensive Cancer Center
Contact Barbara Kahn-Mills
Phone 310 825-2520
Email bkahnmills@mednet.ucla.edu
Status Recruiting
Phase Phase 2
Start date September 29, 2021
Completion date November 1, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT04535323 - Platelet Rich Plasma for the Treatment of Genitourinary Syndrome of Menopause in Patients With Stage 0-III Breast Cancer Phase 1
Recruiting NCT05464810 - Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer Early Phase 1
Active, not recruiting NCT04249622 - Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer Phase 2
Recruiting NCT05929768 - Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer Phase 3
Withdrawn NCT03666819 - Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy Phase 2
Not yet recruiting NCT05930483 - Remotely Delivered, Culturally Tailored Weight Loss Interventions Among Latina Breast Cancer Survivors N/A
Recruiting NCT04862585 - Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel Phase 2/Phase 3
Recruiting NCT03953157 - Dietary and Exercise Interventions in Reducing Side Effects in Patients With Stage I-IIIa Breast Cancer Receiving Aromatase Inhibitors N/A
Recruiting NCT04593277 - Interactive Survivorship Program for the Improvement of Healthcare Resources in Adolescent and Young Adult Cancer Survivors, INSPIRE-AYA Study N/A
Active, not recruiting NCT05086731 - Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer N/A
Recruiting NCT05368428 - Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer N/A
Active, not recruiting NCT04086875 - A Text-based Intervention in Improving Adherence to Hormone Therapy in Patients With Stage I-III Hormone Receptor Positive Breast Cancer N/A
Completed NCT00507923 - Tibetan Yoga in Improving Fatigue and Sleep in Participants With Stage I-III Breast Cancer N/A
Recruiting NCT06058377 - Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer Phase 3
Recruiting NCT05455658 - STEMVAC in Patients With Early Stage Triple Negative Breast Cancer Phase 2
Active, not recruiting NCT04537312 - Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM) N/A
Recruiting NCT05674578 - Health Coaching-Based Navigation at the Conclusion of Treatment for the Support of Black Breast Cancer Survivors N/A
Active, not recruiting NCT05012176 - An Episodic Future Thinking Intervention to Promote Weight Loss in Breast Cancer Survivors N/A
Withdrawn NCT04205071 - Lorcaserin in Treating Chemotherapy-Induced Peripheral Neuropathy in Patients With Stage I-IV Gastrointestinal or Breast Cancer Phase 1
Active, not recruiting NCT01334021 - Genetic Testing in Predicting Tumor Response in Patients With Stage I-III HER2 Negative Invasive Breast Cancer Phase 2