Strawberry compound and exercise may keep breast cancer survivors from becoming frail
NCT ID NCT06113016
First seen Jul 17, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This phase II trial tests whether a natural supplement called fisetin, found in strawberries, combined with exercise can prevent frailty in postmenopausal women who have had early-stage breast cancer. Fisetin may help clear aging cells that cause inflammation and damage healthy tissue. The study compares fisetin alone, exercise alone, both together, and a placebo to see which approach best maintains physical function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a natural compound called fisetin, found in strawberries and other foods, given as a nutritional supplement
- What this could lead to
- If it works, this could point toward a way to prevent frailty in breast cancer survivors, helping them stay active and healthy longer.
- What could go wrong
- This is an early-phase trial with a moderate number of participants, so results may not be conclusive or apply to all survivors. Fisetin's effects on senescent cells are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 164 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Oct 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UCLA / Jonsson Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90095, United States
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UCLA Health Beverly Hills Primary & Specialty Care
RECRUITINGBeverly Hills, California, 90210, United States
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UCLA Health Burbank Primary & Specialty Care
RECRUITINGBurbank, California, 91505, United States
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UCLA Health Cancer Care in Alhambra
RECRUITINGAlhambra, California, 91801, United States
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UCLA Health Primary Care in Marina del Rey
RECRUITINGMarina del Rey, California, 90292, United States
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UCLA Health Primary Care in Pasadena
RECRUITINGPasadena, California, 91105, United States
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- Can a vaccine train the immune system to hunt down hidden breast cancer cells?