Using fisetin to enhance physical function in breast cancer survivors
A Phase II Randomized Double-Blind Placebo-Controlled Study of Fisetin to Improve Physical Function in Breast Cancer Survivors
This study is testing if fisetin, a natural compound from strawberries, can help improve physical function and overall well-being in postmenopausal women who have had chemotherapy for breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Sex | Female |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, pembrolizumab, dasatinib, imatinib, chemotherapy, immunotherapy, radiation |
| Locations | 7 sites (Alhambra, California and 6 other locations) |
| Trial ID | NCT05595499 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effects of fisetin, a natural compound found in strawberries, on improving physical function in postmenopausal women who have undergone chemotherapy for stage I-III breast cancer. The study aims to assess various physical function metrics, including the 6-minute walk distance, grip strength, and overall quality of life. Additionally, it evaluates the impact of fisetin on fatigue, neuropathy, cognitive function, sleep, anxiety, and depression. The trial will also monitor the safety and tolerability of fisetin in this patient population.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women aged 60 and older, or younger women who meet specific hormonal criteria, diagnosed with early-stage breast cancer and treated with chemotherapy within the last 12 months.
Not a fit: Patients with active or recurrent breast cancer or other serious chronic illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved physical function and quality of life for breast cancer survivors post-chemotherapy.
How similar studies have performed: While the use of fisetin in this context is novel, other studies have shown promise in targeting senescent cells for improving health outcomes.
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 aged: \>= 60 years OR
* Women aged \< 60 years AND one of the following conditions is met:
* They have not had any menstrual periods for at least 12 months in the absence of exogenous hormonal treatments, chemotherapy, and/or tamoxifen AND have serum estradiol and follicle-stimulating hormone (FSH) levels confirmed as being within the standard laboratory reference range for postmenopausal females.
* They have documented irreversible bilateral oophorectomy.
* They are receiving ovarian suppression with their breast cancer endocrine therapy
* Women with a diagnosis of early-stage breast cancer (Stage I-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 frail health, defined as a diminished 6-minute walk distance (\< 400m) 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
* 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, ribociclib, abemaciclib, aromatase inhibitors and/or ovarian suppression.
* 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 listed in 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 (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 6 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)
- City of Hope Comprehensive Cancer Center — Duarte, 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, MD — 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.