A Phase II Randomized Placebo-Controlled Study of Fisetin and Exercise to Prevent Frailty in Breast Cancer Survivors

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other, Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• 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

Locations
United States
California
UCLA Health Cancer Care in Alhambra
RECRUITING
Alhambra
UCLA Health Beverly Hills Primary & Specialty Care
RECRUITING
Beverly Hills
UCLA Health Burbank Primary & Specialty Care
RECRUITING
Burbank
UCLA / Jonsson Comprehensive Cancer Center
RECRUITING
Los Angeles
UCLA Health Primary Care in Marina del Rey
RECRUITING
Marina Del Rey
UCLA Health Primary Care in Pasadena
RECRUITING
Pasadena
Contact Information
Primary
Mina S. Sedrak, MD
msedrak@mednet.ucla.edu
310-825-3181
Backup
Kelly Synold
ksynold@mednet.ucla.edu
424-440-3877
Time Frame
Start Date: 2024-07-23
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 164
Treatments
Active_comparator: Arm A (fisetin, physical activity handout)
Patients receive fisetin PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive handout on the importance of physical activity during baseline. Patients undergo collection of blood samples on study.
Experimental: Arm AB (fisetin, tailored exercise training)
Patients receive fisetin PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. 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.
Active_comparator: Arm B (placebo, tailored exercise training)
Patients receive placebo PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. 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.
Active_comparator: Arm C (placebo, physical activity handout)
Patients receive placebo PO on days 1-3 of each cycle. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive handout on the importance of physical activity during baseline. Patients undergo collection of blood samples on study.
Related Therapeutic Areas
Sponsors
Leads: Jonsson Comprehensive Cancer Center
Collaborators: Rising Tide Foundation, National Institutes of Health (NIH), National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov