Using fisetin and exercise to prevent frailty in breast cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effectiveness of fisetin, a natural supplement, combined with exercise in preventing frailty among postmenopausal breast cancer survivors who have undergone chemotherapy. The study aims to assess various physical functions, including walking distance, heart rate, and overall quality of life, using both objective measures and patient-reported outcomes. Participants will engage in physical activity while receiving fisetin to evaluate its impact on health and recovery. The trial also seeks to ensure the safety and tolerability of fisetin in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• UCLA Health Cancer Care in Alhambra
  Alhambra, California, United States Recruiting
• UCLA Health Beverly Hills Primary & Specialty Care
  Beverly Hills, California, United States Recruiting
• UCLA Health Burbank Primary & Specialty Care
  Burbank, California, United States Recruiting
• UCLA / Jonsson Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• UCLA Health Primary Care in Marina del Rey
  Marina del Rey, California, United States Recruiting
• UCLA Health Primary Care in Pasadena
  Pasadena, California, United States Recruiting

Study contacts

• Principal investigator: Mina S Sedrak — UCLA / Jonsson Comprehensive Cancer Center
• Study coordinator: Mina S. Sedrak, MD
• Email: msedrak@mednet.ucla.edu
• Phone: 310-825-3181

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Blended e-Health Program to Help Women with Breast or Gynecologic Cancer Manage Fear of Cancer Progression

  This trial tests a blended online and group program to see if it helps women with breast or gynecologic cancer feel less fear that their cancer could grow or spread.

  Recruiting at 11 sites City of Hope Medical Center · Arcadia, California and 10 other locations · NCT07741968

• Navigation program to boost survivorship support participation for non-metastatic breast cancer survivors

  This program tests whether a patient navigation service helps non-metastatic breast cancer survivors use survivorship support services more often.

  Recruiting Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07699991

• Personalized Exercise Plan for Breast Cancer Survivors on Chemotherapy

  This trial tests whether adding a guided exercise program to a healthy-lifestyle education plan helps breast cancer patients undergoing chemotherapy maintain fitness, heart health, and quality of life.

  Recruiting at 3 sites Wake Forest University Health Sciences · Winston-Salem, North Carolina and 3 other locations · NCT07474090

• Goserelin Injections: Is Upper-Gluteal Dosing as Good as Abdominal Dosing for OFS in Localized and Locally Advanced HR+ Breast Cancer

  This phase 2 trial tests whether giving goserelin acetate injections in the upper gluteal region works as well as abdominal injections for suppressing ovarian function in premenopausal women with localized or locally advanced hormone receptor–positive breast cancer.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07460752

• Resistant potato starch to reduce joint and muscle symptoms in people starting aromatase inhibitors for early-stage or high-risk breast cancer

  This phase II trial will test whether taking resistant potato starch can reduce joint pain and stiffness in people with stage 0–III or high-risk breast cancer who are starting aromatase inhibitor therapy.

  Recruiting Phase 2 University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07443943

• Sleep Changes and Biomarkers After Breast Cancer Treatment

  This project will see how sleep patterns and stress-related biological markers change from treatment through survivorship in people with stage I–III hormone receptor–positive breast cancer.

  Recruiting Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07341503

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.