Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors

NCT05595499 | Recruiting Phase 2 DMC FDA Drug

• 5 other identifiers: 23-001170NCI-2022-08061P30CA016042R21CA277660K76AG074918
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 7

Brief Summary

This phase II trial tests whether fisetin works to improve physical function in women who have received chemotherapy for stage I-III breast cancer treatment. Fisetin is a naturally occurring substance that is found in strawberries and other foods. Fisetin eliminates 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 causes inflammation and damages nearby healthy cells. Studies have shown that chemotherapy causes a build-up of these senescent cells. Giving fisetin may eliminate senescent cells and improve physical function in postmenopausal women who have received chemotherapy for breast cancer.

Conditions

Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Change in 6-minute walk distance (6MWD)

  The 6MWD is a validated measure of physical function. Participants walk at their own pace for 6 minutes and distance (in meters) is measured at the end. Will be treated as a continuous variable. Its distribution will be transformed to normality as appropriate, Initially, a simple t-test will be used to compare the means of 6MWD at Day 60 by treatment groups.

  Baseline to day 60

Secondary Outcomes (17)

• Change in grip strength

  From baseline to day 60

• Change in Short Physical Performance Battery score

  From baseline to day 60

• Change in frailty phenotype

  From baseline to day 60

• Change in physical function component of 36-item Short Form (SF-36)

  From baseline to day 60

• Change in the Borg Rating of Perceived Exertion score

  From baseline to day 60

Study Arms (2)

Arm A (fisetin)

EXPERIMENTAL

Patients receive fisetin PO on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial.

Procedure: Biospecimen Collection; Drug: Fisetin; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm B (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO on the trial. on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial.

Procedure: Biospecimen Collection; Drug: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm A (fisetin); Arm B (placebo)

Fisetin DRUG

Given PO

Also known as: 3,3',4',7-Tetrahydroxyflavone, 7,3',4'-Flavon-3-ol

Arm A (fisetin)

Placebo Administration DRUG

Given PO

Arm B (placebo)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (fisetin); Arm B (placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm A (fisetin); Arm B (placebo)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (7)

UCLA Health Cancer Care in Alhambra

Alhambra, California, 91801, United States

RECRUITING

UCLA Health Beverly Hills Primary & Specialty Care

Beverly Hills, California, 90210, United States

RECRUITING

UCLA Health Burbank Primary & Specialty Care

Burbank, California, 91505, United States

RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

RECRUITING

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

UCLA Health Primary Care in Marina del Rey

Marina del Rey, California, 90292, United States

RECRUITING

UCLA Health Primary Care in Pasadena

Pasadena, California, 91105, United States

RECRUITING

MeSH Terms

Interventions

Specimen Handling; fisetin

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Mina S. Sedrak, MD

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mina S. Sedrak, MD

CONTACT

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

Kelly Synold

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 27, 2022
• Study Start: March 27, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-05

Locations

US (7)