Using fisetin to enhance physical function in breast cancer survivors
Official title: A Phase II Randomized Double-Blind Placebo-Controlled Study of Fisetin to Improve Physical Function in Breast Cancer Survivors
Run by Jonsson Comprehensive Cancer Center · NCT05595499 · Data updated 2026-11-12
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 |
| Sex | Women only |
| Enrollment | 88 (estimated) |
| 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) |
| Status | Recruiting |
| Started | March 27, 2023 |
| Main results expected | August 14, 2027 |
| Study ends | August 14, 2028 |
| Registry record updated | July 17, 2026 |
| Trial ID | NCT05595499 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with active or recurrent breast cancer or other serious chronic illnesses may not benefit from this study.
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 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.
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 gone: While the use of fisetin in this context is novel, other studies have shown promise in targeting senescent cells for improving health outcomes.
Who can join: the full rules
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 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 -
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
Show 1 more location
-
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
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.
-
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.
-
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.
-
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.
-
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.
-
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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.