Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Anatomic Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Early Stage Breast Carcinoma

In brief

This phase II trial tests how well fisetin and exercise works in preventing frailty in breast cancer survivors. Fisetin is a natural substance found in strawberries and other foods and is available as a nutritional supplement. Nutritional supplements may be useful in eliminating cells that have undergone a process called senescence. Senescence is when a cell ages and permanently stops dividing but does not die. Over time, large numbers of these cells build up in tissues throughout the body and can release harmful substances that cause inflammation and damage nearby healthy cells. Giving fisetin may eliminate senescent cells in patients with breast cancer undergoing physical activity.

Key facts

Study ID: NCT06113016
Run by: Jonsson Comprehensive Cancer Center
People needed: 164
Starts: 2024-07-23
Expected to finish: 2031-10-31
Last updated by the study team: 2026-07-30

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Women who are postmenopausal at the start of study treatment
Postmenopausal status will be established as follows: Women who are 50 years or older and who are not menstruating for greater than 12 months will be considered postmenopausal. Women who are less than 50 years with an intact uterus and ovaries must have chemically induced menopause (e.g., ovarian suppression) to be considered postmenopausal
Women with a diagnosis of early-stage breast cancer (stage I, II, III) treated with neo/adjuvant chemotherapy within 12 months of starting study treatment
No evidence of active/recurrent breast cancer or other serious chronic illnesses
Have evidence of pre-frail health, defined as a 6-minute walk distance (400-480m) 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 the Modification of Diet in Renal Disease (MDRD) calculation. GFR (mL/min/1.73 m²) = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American)
Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

Cancer-directed chemotherapy, biological therapy, or immunotherapy within 30 days prior 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 under "Temporary medication adjustment required" may participate if they are otherwise eligible AND the medication can be safely withheld (from immediately before the 1st study agent administration until at least 10 hours after the last study agent administration, 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 its administration 2 days prior to and during study treatment dosing. Exceptions include cannabidiol (CBD), vitamins, probiotics, and fish oil. Other herbal and natural medications 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, low molecular weight heparin, factor Xa inhibitors, etc.)
Issues with tolerating oral medication (such as but not limited to, inability to swallow pills (gastrostomy [g]-tubes not allowed), malabsorption issues, ongoing nausea or vomiting during screening, history of Crohn's, gastric bypass/reduction, or celiac disease)
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Currently participating in another intervention research study seeking to improve functional status, alleviate frailty, muscle strength, exhaustion/fatigue, or cognitive function

Where it is running

UCLA Health Cancer Care in Alhambra — Alhambra, California, United States (enrolling)
UCLA Health Beverly Hills Primary & Specialty Care — Beverly Hills, California, United States (enrolling)
UCLA Health Burbank Primary & Specialty Care — Burbank, California, United States (enrolling)
UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
UCLA Health Primary Care in Marina del Rey — Marina del Rey, California, United States (enrolling)
UCLA Health Primary Care in Pasadena — Pasadena, California, United States (enrolling)

Full record on ClinicalTrials.gov

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