Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors
NCT ID: NCT06113016
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
164 participants
INTERVENTIONAL
2024-07-23
2028-12-30
Brief Summary
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Detailed Description
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I. To determine the effect of fisetin and/or exercise on physical function, as assessed using the 6-minute walk distance (6MWD), in chemotherapy-treated postmenopausal breast cancer survivors.
SECONDARY OBJECTIVES:
I. To determine the effect of fisetin and/or exercise on heart rate and step count, as measured by wearable device.
II. To determine the effect of fisetin on other measures of physical function beyond 6MWD (short physical performance battery \[SPPB\], grip strength, frailty phenotype, physical activity).
III. To determine the effect of fisetin and/or exercise on fatigue (Borg Rating of Perceived Exertion \[RPE\]).
IV. To determine the effect of fisetin and/or exercise on neuropathy (Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 \[QLQ-CIPN20\]).
V. To determine the effect of fisetin and/or exercise on cognition (Patient Reported Outcomes Measurement Information System \[PROMIS\] cognitive function short form).
VI. To determine the effect of fisetin and/or exercise on health-related quality of life (Short Form \[SF\]-36).
VII. To determine the effect of fisetin on local and distant recurrence free survival (RFS).
VIII. To determine the effect of fisetin on breast cancer-specific survival and overall survival.
IX. To evaluate the safety and tolerability (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\]5.0) of fisetin.
X. To estimate rates of adherence to fisetin and/or exercise regimen.
EXPLORATORY OBJECTIVES:
I. To determine the effect of fisetin and/or exercise on p16 expression in peripheral CD3+ T-cells.
II. To determine the effect of fisetin and/or exercise on circulating senescence-associated secretory phenotype (SASP) inflammatory factors in blood and urine.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM AB: Patients receive fisetin orally (PO) on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive individually tailored supervised exercise training consisting of 30-45 minutes of aerobic training and 20-30 minutes of resistance training three times a week over 16 weeks. Patients undergo collection of blood samples on study.
ARM A: Patients receive fisetin PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive handout on the importance of physical activity during baseline. Patients undergo collection of blood samples on study.
ARM B: Patients receive placebo PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive individually tailored supervised exercise training consisting of 30-45 minutes of aerobic training and 20-30 minutes of resistance training three times a week over 16 weeks. Patients undergo collection of blood samples on study.
ARM C: Patients receive placebo PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive handout on the importance of physical activity during baseline. Patients undergo collection of blood samples on study.
Following completion of study intervention, patients are followed up on days 120 and 180 and then annually for up to 3 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Arm A (fisetin, physical activity handout)
Patients receive fisetin PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive handout on the importance of physical activity during baseline. Patients undergo collection of blood samples on study.
Biospecimen Collection
Undergo collection of blood samples
Educational Intervention
Receive handout on physical activity
Fisetin
Given PO
Physical Performance Testing
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm AB (fisetin, tailored exercise training)
Patients receive fisetin PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive individually tailored supervised exercise training consisting of 30-45 minutes of aerobic training and 20-30 minutes of resistance training three times a week over 16 weeks. Patients undergo collection of blood samples on study.
Biospecimen Collection
Undergo collection of blood samples
Exercise Intervention
Receive individually tailored exercise intervention
Fisetin
Given PO
Physical Performance Testing
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm B (placebo, tailored exercise training)
Patients receive placebo PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive individually tailored supervised exercise training consisting of 30-45 minutes of aerobic training and 20-30 minutes of resistance training three times a week over 16 weeks. Patients undergo collection of blood samples on study.
Biospecimen Collection
Undergo collection of blood samples
Exercise Intervention
Receive individually tailored exercise intervention
Physical Performance Testing
Ancillary studies
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm C (placebo, physical activity handout)
Patients receive placebo PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive handout on the importance of physical activity during baseline. Patients undergo collection of blood samples on study.
Biospecimen Collection
Undergo collection of blood samples
Educational Intervention
Receive handout on physical activity
Physical Performance Testing
Ancillary studies
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Biospecimen Collection
Undergo collection of blood samples
Educational Intervention
Receive handout on physical activity
Exercise Intervention
Receive individually tailored exercise intervention
Fisetin
Given PO
Physical Performance Testing
Ancillary studies
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
FEMALE
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Cancer Institute (NCI)
NIH
Rising Tide Foundation
OTHER
Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Mina S Sedrak
Role: PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Locations
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UCLA Health Cancer Care in Alhambra
Alhambra, California, United States
UCLA Health Beverly Hills Primary & Specialty Care
Beverly Hills, California, United States
UCLA Health Burbank Primary & Specialty Care
Burbank, California, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Health Primary Care in Marina del Rey
Marina del Rey, California, United States
UCLA Health Primary Care in Pasadena
Pasadena, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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