Actively Recruiting

Phase 2
FEMALE
NCT05595499

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

Led by Jonsson Comprehensive Cancer Center · Updated on 2025-07-02

88

Participants Needed

7

Research Sites

166 weeks

Total Duration

On this page

Sponsors

J

Jonsson Comprehensive Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase II trial tests whether fisetin works to improve physical function in women who have received chemotherapy for stage I-III breast cancer treatment. Fisetin is a naturally occurring substance that is found in strawberries and other foods. Fisetin eliminates 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 causes inflammation and damages nearby healthy cells. Studies have shown that chemotherapy causes a build-up of these senescent cells. Giving fisetin may eliminate senescent cells and improve physical function in postmenopausal women who have received chemotherapy for breast cancer.

CONDITIONS

Official Title

Fisetin to Improve Physical Function in Stage I-III 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 60 years or older, or women under 60 who meet specific postmenopausal criteria including no menstrual periods for 12 months with confirmed hormone levels, irreversible bilateral oophorectomy, or ovarian suppression
  • Diagnosis of early-stage breast cancer (Stage I-III) treated with neo/adjuvant chemotherapy within 12 months before starting treatment
  • No evidence of active or recurrent breast cancer or serious chronic illnesses
  • Frail health shown by a 6-minute walk distance less than 400 meters at baseline
  • Platelet count greater than 60,000/mm3
  • White blood cell count greater than 2,000/mm3
  • Absolute neutrophil count greater than 500/mm3
  • Hemoglobin level at least 8.0 g/dL
  • Total bilirubin no more than 3 times the upper limit of normal
  • AST and ALT less than or equal to 4 times the upper limit of normal
  • Estimated glomerular filtration rate of at least 30 mL/min/1.73m2
  • Ability to understand and willingness to sign informed consent
Not Eligible

You will not qualify if you...

  • Chemotherapy, biological therapy, or immunotherapy within 30 days before starting treatment, except certain specified drugs
  • Surgery or radiation within 30 days before starting treatment, except minor procedures like outpatient biopsy
  • Use of prohibited medications or herbal supplements with senolytic properties unless safely withheld during dosing
  • Use of potentially senolytic agents like fisetin, quercetin, or certain kinase inhibitors within the last year
  • Therapeutic doses of anticoagulants
  • Difficulty tolerating oral medications such as inability to swallow pills or digestive disorders
  • Any condition judged by the investigator to contraindicate participation due to safety concerns
  • Participation in another intervention study targeting functional status, frailty, muscle strength, fatigue, or cognitive function

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 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

City of Hope Comprehensive Cancer Center

Duarte, California, United States, 91010

Actively Recruiting

5

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States, 90095

Actively Recruiting

6

UCLA Health Primary Care in Marina del Rey

Marina del Rey, California, United States, 90292

Actively Recruiting

7

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

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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