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RecruitingPhase 2

Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors

A Phase II Randomized Placebo-Controlled Study of Fisetin and Exercise to Prevent Frailty 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: 16 weeks, 3 years
  • Procedures mentioned: Wearing a device, Questionnaires, 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 and/or exercise on heart rate and step count, as measured by wearable device."
  • "To determine the effect of fisetin and/or exercise on neuropathy (Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 \[QLQ-CIPN20\])."
  • "Patients also receive individually tailored supervised exercise training consisting of 30-45 minutes of aerobic training and 20-30 minutes of resistance training three times a week over 16 weeks."
  • "Patients undergo collection of blood samples on study."
  • "Following completion of study intervention, patients are followed up on days 120 and 180 and then annually 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 and exercise can help prevent frailty, or becoming weak and less able to do daily tasks. Fisetin is a natural substance found in strawberries and other foods and sold as a supplement. The study is for women past menopause who have been treated for breast cancer and show early signs of frailty.

This phase II trial tests how well fisetin and exercise works in preventing frailty in breast cancer survivors. Fisetin is a natural substance found in strawberries and other foods and is available as a nutritional supplement. Nutritional supplements may be useful in eliminating 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 cause inflammation and damage nearby healthy cells. Giving fisetin may eliminate senescent cells in patients with breast cancer undergoing physical activity.

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

Eligibility

Who can join

  • Women past menopause when study treatment starts. Those age 50 or older must have had no periods for over 12 months. Those under 50 who still have their uterus and ovaries must have menopause caused by medicine.
  • Had stage I, II, or III breast cancer and received chemotherapy before or after surgery within 12 months before study treatment starts.
  • Have no signs of active breast cancer or cancer that has come back, and no other serious long-term illnesses.
  • Show early signs of frailty: can walk 400–480 meters during a 6-minute walk test.
  • Meet blood count limits: platelets over 60,000, white blood cells over 2,000, and neutrophils (infection-fighting cells) over 500 per cubic millimeter; hemoglobin at least 8.0 g/dL.
  • Meet liver test limits: bilirubin no more than 3 times the upper normal limit; AST and ALT no more than 4 times that limit.
  • Have an estimated kidney filtering rate (eGFR) of at least 30 mL/min/1.73 m².
  • Can understand the study and are willing to sign a consent form.

Who can't join

  • Had cancer chemotherapy, biological therapy, or immune therapy within 30 days before study treatment. Trastuzumab, pertuzumab, pembrolizumab, tamoxifen, and aromatase inhibitors are allowed.
  • Had surgery or radiation within 30 days before study treatment. Minor procedures, such as an outpatient biopsy, are allowed.
  • Take medicines the study does not allow. Some may be allowed if safely stopped just before the first study dose until at least 10 hours after the last dose in each dosing period.
  • Cannot or will not stop herbs or natural products that may remove aged cells, such as curcumin, kava kava, or St. John's wort, for 2 days before and during study dosing. CBD, vitamins, probiotics, and fish oil are allowed; the study doctor decides about other products.
  • Used products that may remove aged cells within the past year: fisetin, quercetin, luteolin, dasatinib, imatinib or similar drugs, piperlongumine, or navitoclax.
  • Take treatment-level doses of blood thinners, such as warfarin or heparin.
  • Have trouble taking or absorbing pills, ongoing nausea or vomiting at screening, or a history of Crohn's disease, celiac disease, or stomach bypass or reduction surgery. Feeding tubes into the stomach are not allowed. Other conditions may also rule out joining if the study doctor has safety concerns.
  • Are in another treatment study aimed at improving daily function, frailty, muscle 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 who are 50 years or older and who are not menstruating for greater than 12 months will be considered postmenopausal. Women who are less than 50 years with an intact uterus and ovaries must have chemically induced menopause (e.g., ovarian suppression) to be considered postmenopausal * Women with a diagnosis of early-stage breast cancer (stage I, II, 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 pre-frail health, defined as a 6-minute walk distance (400-480m) 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. GFR (mL/min/1.73 m²) = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American) * 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, and aromatase inhibitors * 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 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 (gastrostomy \[g\]-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 (6)

CA