Using fisetin and exercise to prevent frailty in breast cancer survivors
A Phase II Randomized Placebo-Controlled Study of Fisetin and Exercise to Prevent Frailty in Breast Cancer Survivors
This study is testing whether taking fisetin, a natural supplement, along with exercise can help prevent frailty in postmenopausal breast cancer survivors who have had chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Sex | Female |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, pembrolizumab, dasatinib, imatinib, chemotherapy, immunotherapy, radiation |
| Locations | 6 sites (Alhambra, California and 5 other locations) |
| Trial ID | NCT06113016 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women who have been treated for early-stage breast cancer and exhibit signs of pre-frailty.
Not a fit: Patients with active or recurrent breast cancer or serious chronic illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve physical function and quality of life for breast cancer survivors.
How similar studies have performed: Other studies have shown promise in using nutritional supplements and exercise to improve outcomes in cancer survivors, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Alhambra, California and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.