Back to search results

Fisetin and Exercise for Frailty Prevention in Breast Cancer Survivors

This study is looking at whether fisetin, a natural substance found in foods like strawberries, combined with exercise, can help prevent frailty in postmenopausal women who have survived breast cancer. Fisetin may work by clearing out 'senescent cells' (cells that have aged and stopped dividing but don't die, potentially causing harm). The study will measure changes in your walking ability (6-minute walk distance) to see if these interventions are successful. We are looking for 164 women who have had Stage I, II, or III breast cancer. The current recruitment status is unclear.

Study design
This is an interventional study, but the phase is not specified. It plans to enroll 164 participants.
What's involved
You would provide blood samples, receive a handout on physical activity, get a personalized exercise plan, and take fisetin by mouth. You would also undergo physical performance testing.
Compensation
Not stated in the trial record.
Follow-up
Your walking distance will be measured from the start of the study to day 120.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06113016

Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors

Recruiting
PHASE2All AgesInterventionalSupportive care
Jonsson Comprehensive Cancer Center
~164 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Biospecimen CollectionEducational InterventionExercise InterventionFisetinPhysical Performance TestingPlacebo Administration

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in 6 minute walk distance (6MWD)
Measured over From baseline to day 120

Conditions

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

Explore related trials

Breast Carcinoma

Where it's being run

6 sites across 1 states
California6

Study leadership

  • Mina S Sedrak · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

Who to contact

Mina S. Sedrak, MD
[email protected]
310-825-3181
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Change in 6 minute walk distance (6MWD)From baseline to day 120

    The 6MWD will assess the distance walked over 6 minutes and is measured in meters. A linear model will be fit to outcome variable (change score) with a factor variable representing the four study arms and control for baseline 6MWD, site, and age stratum. The analysis will be conducted as intention-to-treat analysis. Will conduct an as-treated analysis, comparing the treatments received (instead of as-randomized).