COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-09-29

Study Completion:2024-11-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04290897

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 74 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Principal Investigator

Patricia A Ganz

PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Study Locations (Sites)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095

United States

Collaborators and Investigators

Sponsor: Jonsson Comprehensive Cancer Center

Patricia A Ganz, PRINCIPAL_INVESTIGATOR, UCLA / Jonsson Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-29

Study Completion Date2024-11-12

Study Record Updates

Study Start Date2021-09-29

Study Completion Date2024-11-12

Terms related to this study

Additional Relevant 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
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