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Prevention study for Anatomic Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8
Official title Prevention of Frailty With Fisetin and Exercise in Breast Cancer Survivors
ClinicalTrials.gov ID: NCT06113016
What this study is testing
What is Fisetin?
Fisetin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anatomic stage i breast cancer american joint committee on cancer (ajcc) v8.
Also referred to as 3,3',4',7-Tetrahydroxyflavone, 7,3',4'-Flavon-3-ol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, women only
You may be able to join if
- 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...
- Women with a diagnosis of early-stage breast cancer (stage I, II, III) treated with neo/adjuvant chemotherapy within 12 months of starting study...
- 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
You likely can't join if
- Cancer-directed chemotherapy, biological therapy, or immunotherapy within 30 days prior to the start of study treatment. Exceptions include...
- Surgery and/or radiation within the last 30 days of starting study treatment (Exception: invasive non-major procedures such as an outpatient biopsy)
- people taking medications that are considered prohibited
- Exception: people taking any of the medications under "Temporary medication adjustment required" may participate if they are otherwise eligible AND...
- 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...
- people taking potentially senolytic agents within the last year: fisetin, quercetin, luteolin, dasatinib or imatinib (or other tyrosine kinase...
See the full eligibility 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...
- 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...
- Ability to understand and the willingness to sign a written informed consent document
- 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)
- people taking medications that are considered prohibited
- Exception: people 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...
- 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...
- people taking potentially senolytic agents within the last year: fisetin, quercetin, luteolin, dasatinib or imatinib (or other tyrosine kinase inhibitors), piperlongumine, or navitoclax
- people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Alhambra, California, United States
- Beverly Hills, California, United States
- Burbank, California, United States
- Los Angeles, California, United States
- Marina del Rey, California, United States
- Pasadena, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alhambra, California, United States; Beverly Hills, California, United States; Burbank, California, United States; Los Angeles, California, United States; Marina del Rey, California, United States; Pasadena, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.