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

Part of paid clinical trials in Alhambra, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT05595499
Phase
PHASE2
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Fisetin — DRUG
    Given PO
  • Placebo Administration — DRUG
    Given PO
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Mar 27, 2023
Status verified
May 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (fisetin)
    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.
  • Placebo Comparator: Arm B (placebo)
    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.

Primary Outcome Measure

Change in 6-minute walk distance (6MWD) [ Time Frame: Baseline to day 60 ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
UCLA Health Cancer Care in AlhambraAlhambraCalifornia91801
Mina S. Sedrak, MD
310-825-3181
UCLA Health Beverly Hills Primary & Specialty CareBeverly HillsCalifornia90210
Mina S. Sedrak, MD
310-825-3181
UCLA Health Burbank Primary & Specialty CareBurbankCalifornia91505
Mina S. Sedrak, MD
310-825-3181
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010
Keilani Luna
909-809-9338
Marie D. Yee, MD
626-256-4673
Lisa D. Yee, MD (PRINCIPAL_INVESTIGATOR)
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Mina S. Sedrak
310-825-3181
Mina S. Sedrak (PRINCIPAL_INVESTIGATOR)
UCLA Health Primary Care in Marina del ReyMarina del ReyCalifornia90292
Mina S. Sedrak, MD
310-825-3181
UCLA Health Primary Care in PasadenaPasadenaCalifornia91105
Mina S. Sedrak, MD
310-825-3181

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