Recruiting
Phase 2

Fisetin & Exercise

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT06113016

Conditions

Anatomic Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Early Stage Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Educational Intervention

Exercise Intervention

Fisetin

Physical Performance Testing

Study Details

Brief summary:

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

Anatomic Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Early Stage Breast Carcinoma

Study ID

NCT06113016

Start date

Jul 23, 2024

Status verified date

Jul, 2026

Completion date

Oct 31, 2031

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

active comparator: 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.

active comparator: 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.

Interventions

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

Primary outcome measure

  • Change in 6 minute walk distance (6MWD) [ Time Frame: From baseline to day 120 ]

Central Contacts and Locations

Central contacts

Mina S. Sedrak, MD

310-825-3181msedrak@mednet.ucla.edu

Kelly Synold

424-440-3877ksynold@mednet.ucla.edu

Locations

UCLA Health Cancer Care in Alhambra

Recruiting

Alhambra, California, United States, 91801

Contacts

Mina S. Sedrak, MD

310-825-3181msedrak@mednet.ucla.edu

UCLA Health Beverly Hills Primary & Specialty Care

Recruiting

Beverly Hills, California, United States, 90210

Contacts

Mina S. Sedrak, MD

310-825-3181msedrak@mednet.ucla.edu

UCLA Health Burbank Primary & Specialty Care

Recruiting

Burbank, California, United States, 91505

Contacts

Mina S. Sedrak, MD

310-8253181msedrak@mednet.ucla.edu

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Mina S. Sedrak

310-825-3181msedrak@mednet.ucla.edu

Principal Investigator:

Mina S. Sedrak

UCLA Health Primary Care in Marina del Rey

Recruiting

Marina del Rey, California, United States, 90292

Contacts

Mina S. sedrak, MD

310-825-3181msedrak@mednet.ucla.edu

UCLA Health Primary Care in Pasadena

Recruiting

Pasadena, California, United States, 91105

Contacts

Mina S. Sedrak, MD

310-825-3181msedrak@mednet.ucla.edu

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-07-30.