Back to search results

Fisetin to Improve Physical Function in Breast Cancer Survivors

This study is testing if fisetin, a natural substance found in foods like strawberries, can improve physical function in women who have completed chemotherapy for stage I-III breast cancer. Chemotherapy can cause a build-up of 'senescent cells' (cells that stop dividing but don't die), which can lead to inflammation and damage. Fisetin is thought to help remove these cells. The study will compare fisetin to a placebo (an inactive substance) to see if it improves how far participants can walk in six minutes. You may be able to join if you are a postmenopausal woman who has had stage I-III breast cancer.

Study design
This interventional study plans to enroll 88 participants. It compares the effects of fisetin to a placebo.
What's involved
You would provide blood samples and complete questionnaires and quality-of-life assessments. You would take either fisetin or a placebo by mouth.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, change in 6-minute walk distance, is measured from baseline to day 60.

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

NCT05595499

Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors

Recruiting
PHASE2All AgesInterventionalTreatment
Jonsson Comprehensive Cancer Center
~88 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Biospecimen CollectionFisetinPlacebo AdministrationQuality-of-Life AssessmentQuestionnaire Administration

At a glance

Recruiting sites
7 of 7 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 Baseline to day 60

Conditions

Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8

Explore related trials

Breast Carcinoma

Where it's being run

7 sites across 1 states
California7

Study leadership

  • Mina S. Sedrak, MD · 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.
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 absence of exogenous hormonal treatments, chemotherapy, and/or tamoxifen AND have serum estradiol and follicle-stimulating hormone (FSH) levels confirmed as being within the standard laboratory reference range for postmenopausal females.
They have documented irreversible bilateral oophorectomy.
They are receiving ovarian suppression with their breast cancer endocrine therapy
Women with a diagnosis of early-stage breast cancer (Stage I-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 frail health, defined as a diminished 6-minute walk distance (\< 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 the Modification of Diet in Renal Disease (MDRD) calculation
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, ribociclib, abemaciclib, aromatase inhibitors and/or ovarian suppression.
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 "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 (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)Baseline to day 60

    The 6MWD is a validated measure of physical function. Participants walk at their own pace for 6 minutes and distance (in meters) is measured at the end. Will be treated as a continuous variable. Its distribution will be transformed to normality as appropriate, Initially, a simple t-test will be used to compare the means of 6MWD at Day 60 by treatment groups.