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RecruitingPhase 2

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

A Phase II Randomized Double-Blind Placebo-Controlled Study of Fisetin to Improve Physical Function in Breast Cancer Survivors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks, 3 years
  • Procedures mentioned: Questionnaires, Pills, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To determine the effect of fisetin on other measures of physical function (grip strength, short physical performance battery \[SPPB\], frailty phenotype, physical function component of the 36 item short form survey \[SF-36\])."
  • "To determine the effect of fisetin on neuropathy (Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 \[QLQ-CIPN20\])."
  • "To estimate rates of adherence to fisetin (pill diary)."
  • "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."
  • "After completion of study treatment, patients are followed up yearly for up to 3 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether fisetin can improve physical function in women after menopause who had chemotherapy for stage I–III breast cancer. Fisetin is a substance found in strawberries and other foods that may remove aging cells. The study is for women with reduced walking ability who had chemotherapy within the past 12 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a woman who meets the study’s rules for menopause: age 60 or older, or under 60 with certain period and hormone test results, both ovaries removed, or treatment that stops the ovaries from working.
  • Have stage I–III breast cancer treated with chemotherapy before or after surgery within 12 months of starting study treatment.
  • Have no signs of active or returning breast cancer and no other serious long-term illness.
  • Walk less than 400 meters in a 6-minute walking test.
  • Meet blood count limits: platelets above 60,000, white blood cells above 2,000, and neutrophils, a type of white blood cell, above 500 per cubic millimeter; hemoglobin at least 8 g/dL.
  • Meet liver test limits: bilirubin no more than 3 times the normal upper limit, and AST and ALT no more than 4 times that limit.
  • Have an estimated kidney filtering rate, called eGFR, of at least 30.
  • Be able to understand and willing to sign a consent form.

Who can't join

  • Have certain cancer drug treatments within 30 days before study treatment. Exceptions include trastuzumab, pertuzumab, pembrolizumab, tamoxifen, ribociclib, abemaciclib, aromatase inhibitors, and treatment that stops the ovaries from working.
  • Have surgery or radiation within 30 days before study treatment, except minor procedures such as an outpatient biopsy.
  • Take medicines the study does not allow. Some may be allowed if safely paused from just before each dosing period until at least 10 hours after its last dose.
  • Cannot or will not stop certain herbs or natural products, such as curcumin, kava kava, or St. John’s wort, 2 days before and during study dosing. CBD, vitamins, probiotics, and fish oil are exceptions; the clinician decides about other products.
  • Have taken fisetin, quercetin, luteolin, dasatinib, imatinib or similar drugs, piperlongumine, or navitoclax within the past year. These may remove aging cells.
  • Take treatment-level doses of blood thinners, such as warfarin or heparin.
  • Have trouble taking or absorbing pills, ongoing nausea or vomiting during screening, Crohn’s disease, celiac disease, or past stomach bypass or reduction surgery. Feeding tubes are not allowed.
  • Have another condition the study doctor considers unsafe, or be in another treatment study aimed at improving physical function, frailty, strength, tiredness, or thinking skills.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (7)

CA