NCT05595499 · Jonsson Comprehensive Cancer Center
Fisetin to Improve Physical Function in Stage I-III Breast Cancer Survivors
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo collection of blood samples
DRUG
Fisetin
Given PO
DRUG
Placebo Administration
Given PO
OTHER
Quality-of-Life Assessment
Ancillary studies
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
Change in 6-minute walk distance (6MWD)
Time frame: Baseline to day 60
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 dimin
Where
- Alhambra, California
- Beverly Hills, California
- Burbank, California
- Duarte, California
- Los Angeles, California
- Marina del Rey, California
- Pasadena, California
Collaborators
National Cancer Institute (NCI), National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2025 · Source of record for eligibility and locations