Actively Recruiting

Phase 2
FEMALE
NCT06113016

Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors

Led by Jonsson Comprehensive Cancer Center · Updated on 2025-07-08

164

Participants Needed

6

Research Sites

231 weeks

Total Duration

On this page

Sponsors

J

Jonsson Comprehensive Cancer Center

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women who are postmenopausal at the start of study treatment
  • Women aged 50 years or older who have not menstruated for more than 12 months, or women under 50 with chemically induced menopause
  • Diagnosis of early-stage breast cancer (stage I, II, or III) treated with neo/adjuvant chemotherapy within 12 months before starting treatment
  • No evidence of active or recurrent breast cancer or other serious chronic illnesses
  • Evidence of pre-frail health, defined as a 6-minute walk distance between 400 and 480 meters at baseline
  • Platelet count greater than 60,000/mm^3
  • White blood cell count greater than 2,000/mm^3
  • Absolute neutrophil count greater than 500/mm^3
  • Hemoglobin level at least 8.0 g/dL
  • Total bilirubin less than or equal to 3.0 times the upper limit of normal
  • AST (aspartate aminotransferase) less than or equal to 4.0 times the upper limit of normal
  • ALT (alanine aminotransferase) less than or equal to 4.0 times the upper limit of normal
  • Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m^2 calculated by MDRD formula
  • Ability to understand and willingness to sign informed consent
Not Eligible

You will not qualify if you...

  • Receiving cancer-directed chemotherapy, biological therapy, or immunotherapy within 30 days before starting treatment, except trastuzumab, pertuzumab, pembrolizumab, tamoxifen, or aromatase inhibitors
  • Surgery or radiation within 30 days before treatment, except minor outpatient procedures such as biopsy
  • Taking prohibited medications unless they can be safely withheld during treatment dosing
  • Taking herbal or natural medications with potential senolytic properties (e.g., curcumin, kava kava, St. John's wort) and unable or unwilling to stop 2 days before and during treatment, except CBD, vitamins, probiotics, and fish oil
  • Use of certain senolytic agents (fisetin, quercetin, luteolin, dasatinib, imatinib, piperlongumine, navitoclax) within the past year
  • Using therapeutic doses of anticoagulants like warfarin, heparin, or factor Xa inhibitors
  • Difficulty tolerating oral medication, including inability to swallow pills or malabsorption issues
  • Any condition that in the investigator's judgment makes participation unsafe
  • Currently enrolled in another research study targeting functional status, frailty, muscle strength, fatigue, or cognitive function

AI-Screening

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Trial Site Locations

Total: 6 locations

1

UCLA Health Cancer Care in Alhambra

Alhambra, California, United States, 91801

Actively Recruiting

2

UCLA Health Beverly Hills Primary & Specialty Care

Beverly Hills, California, United States, 90210

Actively Recruiting

3

UCLA Health Burbank Primary & Specialty Care

Burbank, California, United States, 91505

Actively Recruiting

4

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States, 90095

Actively Recruiting

5

UCLA Health Primary Care in Marina del Rey

Marina del Rey, California, United States, 90292

Actively Recruiting

6

UCLA Health Primary Care in Pasadena

Pasadena, California, United States, 91105

Actively Recruiting

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Research Team

M

Mina S. Sedrak, MD

CONTACT

K

Kelly Synold

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

4

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