Phase
Condition
N/ATreatment
Quality-of-Life Assessment
Fisetin
Questionnaire Administration
Clinical Study ID
Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Women who are postmenopausal at the start of study treatment.
Postmenopausal status will be established as follows:
Women aged: >= 60 years OR
Women aged < 60 years AND one of the following conditions is met:
They have not had any menstrual periods for at least 12 months in the absenceof exogenous hormonal treatments, chemotherapy, and/or tamoxifen AND have serumestradiol and follicle-stimulating hormone (FSH) levels confirmed as beingwithin the standard laboratory reference range for postmenopausal females.
They have documented irreversible bilateral oophorectomy.
They are receiving ovarian suppression with their breast cancer endocrinetherapy
Women with a diagnosis of early-stage breast cancer (Stage I-III) treatedwith neo/adjuvant chemotherapy within 12 months of starting studytreatment
No evidence of active/recurrent breast cancer or other serious chronicillnesses
Have evidence of frail health, defined as a diminished 6-minute walkdistance (< 400m) at baseline
Platelets > 60,000/mm^3
White blood cell count > 2,000/mm^3
Absolute neutrophil count > 500/mm^3
Hemoglobin >= 8.0 g/dL
Total bilirubin =< 3.0 X upper limit of normal (ULN)
Aspartate aminotransferase (AST) =< 4.0 x ULN
Alanine aminotransferase (ALT) =< 4.0 x ULN
Estimated glomerular filtration rate (eGFR) of >= 30mL/min/1.73m^2 per theModification of Diet in Renal Disease (MDRD) calculation
Ability to understand and the willingness to sign a written informedconsent document
Exclusion
Exclusion Criteria:
Cancer-directed chemotherapy, biological therapy, or immunotherapy within 30 daysprior to the start of study treatment. Exceptions include: trastuzumab, pertuzumab,pembrolizumab, tamoxifen, and aromatase inhibitors
Surgery and/or radiation within the last 30 days of starting study treatment (Exception: invasive non- major procedures such as an outpatient biopsy)
Subjects taking medications that are considered prohibited.
Exception: Subjects taking any of the medications listed in under "Temporarymedication adjustment required" may participate if they are otherwise eligibleAND the medication can be safely withheld (from immediately before the 1ststudy agent administration until at least 10 hours after the last study agentadministration, for each dosing interval)
On herbal and natural medications with possible senolytic properties (i.e.,curcumin, kava kava, St. John's wort) and are unable or unwilling to hold itsadministration 2 days prior to and during study treatment dosing. Exceptions includecannabidiol (CBD), vitamins, probiotics, and fish oil. Other herbal and naturalmedications may be permitted or prohibited per clinician discretion
Subjects taking potentially senolytic agents within the last year: fisetin,quercetin, luteolin, dasatinib or imatinib (or other tyrosine kinase inhibitors),piperlongumine, or navitoclax
Subjects on therapeutic doses of anticoagulants (e.g., warfarin, heparin, lowmolecular weight heparin, factor Xa inhibitors, etc.)
Issues with tolerating oral medication (such as but not limited to, inability toswallow pills (g-tubes not allowed), malabsorption issues, ongoing nausea orvomiting during screening, history of Crohn's, gastric bypass/reduction, or celiacdisease)
Any other condition that would, in the Investigator's judgment, contraindicate thepatient's participation in the clinical study due to safety concerns with clinicalstudy procedures
Currently participating in another intervention research study seeking to improvefunctional status, alleviate frailty, muscle strength, exhaustion/fatigue, orcognitive function
Study Design
Study Description
Connect with a study center
UCLA Health Cancer Care in Alhambra
Alhambra, California 91801
United StatesActive - Recruiting
UCLA Health Beverly Hills Primary & Specialty Care
Beverly Hills, California 90210
United StatesActive - Recruiting
UCLA Health Burbank Primary & Specialty Care
Burbank, California 91505
United StatesActive - Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United StatesActive - Recruiting
City of Hope Medical Center
Duarte, California 91010
United StatesSite Not Available
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California 90095
United StatesActive - Recruiting
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California 90095
United StatesActive - Recruiting
UCLA Health Primary Care in Marina del Rey
Marina del Rey, California 90292
United StatesActive - Recruiting
UCLA Health Primary Care in Pasadena
Pasadena, California 91105
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.